| Lot Number UNKNOWN |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Autoimmune Disorder (1732); Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Inflammation (1932); Rash (2033); Dysphasia (2195); Fluid Discharge (2686)
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| Event Date 03/01/2022 |
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Event Type
Injury
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Event Description
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Series of red dots appeared on their lower right leg overnight/spread to their arms, especially to their right hand [red spotty rash].Rash (lesions) on all their limbs, particularly on the leg of the injection/first lesion appeared toward the end of march, on their right ankle below the knee injected, grew to the size of $2 coin over months [rash].Spread to the roof of their mouth, which made speaking and eating difficult [speech impairment nos].Spread to the roof of their mouth, which made speaking and eating difficult [unable to eat].Oozing clear liquid [skin oozing].Ankle became infected [localised infection].Sometimes bleeding [skin bleeding].Inflammatory response [inflammatory reaction].Case narrative: initial information received on 15-nov-2022 regarding an unsolicited valid social media serious case received from a consumer from canada.This case involves a 79 years old female patient who was treated with medical device hylan g-f 20, sodium hyaluronate [synvisc one] and the rash spread to the roof of their mouth, which made speaking and eating difficult, rash (lesions) on all their limbs, particularly on the leg of the injection/first lesion appeared toward the end of march, on their right ankle below the knee injected, grew to the size of $2 coin over months, oozing clear liquid, series of red dots appeared on their lower right leg overnight/spread to their arms, especially to their right hand, ankle became infected, sometimes bleeding and inflammatory response.The patient had no medical history, risk factor.The past medical treatment(s), vaccination(s) and family history were not provided.The patient was highly allergic to metals (nickel and cobalt) in a knee replacement (ongoing).On (b)(6) 2022, the patient received synvisc one (hylan g-f 20, sodium hyaluronate) injection dosage 6 ml (lot, frequency, route, strength - unknown) for arthritis and wear.Since an unknown date in on (b)(6) 2022, after few days, patient had a rash (lesions) on all their limbs, particularly on the leg of the injection (rash) (intervention required), over a period of 8 months.The first lesion appeared toward the end of march, on their right ankle below the knee injected.It did not heal and grew to the size of $2 coin over months.Patient was sent to a cancer clinic for analysis but the cancer test was negative.On an unknown date in on (b)(6) 2022, after 4 months approximately, during a terrible heat wave, a series of red dots appeared on their lower right leg overnight (rash macular) (intervention required), they grew in the same pattern, oozing clear liquid (skin weeping), sometimes bleeding (skin haemorrhage).It spread to the roof of their mouth, which made speaking and eating difficult (speech disorder and eating disorder).Then spread to their arms, especially to their right hand.All this time the tests showed no infection except initially when their ankle became infected (infection) (onset: on (b)(6) 2022 and latency: 4 months approximately).Antibiotics (cephalexin) cleared their ankle lesion and their mouth's.All indications since have suggested an inflammatory response (inflammation) (onset: on (b)(6) 2022 and latency: 4 months approximately).Patient did not consider synvisc-one as a cause until a few weeks ago when they were considering another shot as the first one was helpful and stated that they were highly allergic to metals (nickel and cobalt) in a knee replacement.The rash/lesions were now healing, although perhaps half a dozen were small and emerging and a few larger ones were still active.It seemed to be responding to a powerful steroid cream.Patient thought that perhaps whatever was causing this reaction in their system was lessening over time.Patient was going to see their doctor on the on (b)(6) 2022.The healthcare professional was unaware of the skin condition so patient asked to wait to contact him until after they have seen him.Patient had decided not to have a second injection of the uncertainty about the cause.Action taken: not applicable for all events.Corrective treatment: cefalexin (cephalexin) for infection, rash macular; steroid cream (unknown) for rash, macular rash; not reported for rest of the events.Outcome: recovered/resolved for ankle became infected; recovering/resolving for rest of the events.A product technical complaint was initiated and results were pending for the same.
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Manufacturer Narrative
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Sanofi company comment 22-nov-2022.This case involves a 79 years old female patient who was treated with medical device hylan g-f 20, sodium hyaluronate [synvisc one] and the patient had rash (lesions) on all their limbs, particularly on the leg of the injection/first lesion appeared toward the end of march, on their right ankle below the knee injected, grew to the size of $2 coin over months and series of red dots appeared on their lower right leg overnight/spread to their arms, especially to their right hand, which required intervention with steroid usage.Based on limited information provided, causal role of suspect product cannot be excluded.Case will be re-evaluated post further update on the patients past drug history, concomitant medications.
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Manufacturer Narrative
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Sanofi company comment for follow-up dated 24-nov-2022.Follow up information received does not change prior case assessment this case involves a 79 years old female patient who was treated with medical device hylan g-f 20, sodium hyaluronate [synvisc one] and the patient had rash (lesions) on all their limbs, particularly on the leg of the injection/first lesion appeared toward the end of (b)(6), on their right ankle below the knee injected, grew to the size of $2 coin over months and series of red dots appeared on their lower right leg overnight/spread to their arms, especially to their right hand, which required intervention with steroid usage, an autoimmune response, and overnight in (b)(6) suddenly had 10 red dots on my lower leg, and they grew and then developed into the same lesions as the others and responded identical in appearance.Based on limited information provided, causal role of suspect product cannot be excluded.Case will be re-evaluated post further update on the patients past drug history, concomitant medications.
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Event Description
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Series of red dots appeared on their lower right leg overnight/spread to their arms, especially to their right hand [red spotty rash].Rash (lesions) on all their limbs, particularly on the leg of the injection/first lesion appeared toward the end of (b)(6), on their right ankle below the knee injected, grew to the size of $2 coin over months, unexplained body rash about 8 months ago [rash] an autoimmune response [autoimmune disorder nos].Overnight in (b)(6) suddenly had 10 red dots on my lower leg, and they grew and then developed into the same lesions as the others and responded identical in appearance [red rash].Spread to the roof of their mouth, which made speaking and eating difficult [speech impairment nos].Spread to the roof of their mouth, which made speaking and eating difficult [unable to eat] oozing clear liquid [skin oozing] ankle became infected [localised infection] sometimes bleeding [skin bleeding] inflammatory response [inflammatory reaction].Case narrative: initial information received on 15-nov-2022 regarding an unsolicited valid social media serious case received from a consumer from (b)(6).This case involves a 79 years old female patient who was treated with medical device hylan g-f 20, sodium hyaluronate [synvisc one]and the rash spread to the roof of their mouth, which made speaking and eating difficult, rash (lesions) on all their limbs, particularly on the leg of the injection/first lesion appeared toward the end of (b)(6), on their right ankle below the knee injected, grew to the size of $2 coin over months, oozing clear liquid, series of red dots appeared on their lower right leg overnight/spread to their arms, especially to their right hand, ankle became infected, sometimes bleeding and inflammatory response., an autoimmune response, and overnight in (b)(6) suddenly had 10 red dots on my lower leg, and they grew and then developed into the same lesions as the others and responded identical in appearance.The patient had no medical history, risk factor.The past medical treatment(s), vaccination(s) and family history were not provided.The patient was highly allergic to metals (nickel and cobalt) in a knee replacement (ongoing).Concurrent condition included celiac disease.On (b)(6) 2022, the patient received synvisc one injection dosage 6 ml once having the strength 48mg/6ml (lot, route- unknown) for arthritis and wear.Information on batch number was requested.Since an unknown date in (b)(6) 2022, after few days, patient had a rash (lesions) on all their limbs, particularly on the leg of the injection (rash) (intervention required), over a period of 8 months.The first lesion appeared toward the end of (b)(6), on their right ankle below the knee injected.It did not heal and grew to the size of $2 coin over months.Patient was sent to a cancer clinic for analysis but the cancer test was negative.On an unknown date in (b)(6) 2022, after 4 months approximately, during a terrible heat wave, a series of red dots appeared on their lower right leg overnight (rash macular) (intervention required), they grew in the same pattern, oozing clear liquid (skin weeping), sometimes bleeding (skin haemorrhage).It spread to the roof of their mouth, which made speaking and eating difficult (speech disorder and eating disorder).Then spread to their arms, especially to their right hand.All this time the tests showed no infection except initially when their ankle became infected (infection) (onset: (b)(6) 2022 and latency: 4 months approximately).Antibiotics (cephalexin) cleared their ankle lesion and their mouth's.All indications since have suggested an inflammatory response (inflammation) (onset: (b)(6) 2022 and latency: 4 months approximately).Patient did not consider synvisc-one as a cause until a few weeks ago when they were considering another shot as the first one was helpful and stated that they were highly allergic to metals (nickel and cobalt) in a knee replacement.The rash/lesions were now healing, although perhaps half a dozen were small and emerging and a few larger ones were still active.It seemed to be responding to a powerful steroid cream.Patient thought that perhaps whatever was causing this reaction in their system was lessening over time.Patient was going to see their doctor on the (b)(6) 2022.The healthcare professional was unaware of the skin condition so patient asked to wait to contact him until after they have seen him.Patient had decided not to have a second injection of the uncertainty about the cause.After a latency of few days approximately,patient received in injection on (b)(6) 2022 in r(right) knee.First lesion appeared a few days later on my r ankle, then it grew to a toney sized mark.Went for cancer tests, and they were negative.Lesions then started on the roof of my mouth, and overnight in (b)(6) suddenly had 10 red dots on my lower leg (rash erythematous) (intervention required), and they grew and then developed into the same lesions as the others and responded identical in appearance.Then since (b)(6) it spread to my other leg, and thigh and hip and upper back.Then became severe on my arms and especially on my r hand (rash) (intervention required).Patient had 2 biopsies and 2 swabs and they indicated an autoimmune response (autoimmune disorder) (medically significant).She was taking steroid and cream presently.Patient had inquired about the ingredients of synvisc-one on (b)(6) 2022 and were wondering if it contained gluten as they had celiac disease.Action taken: not applicable for all events.Corrective treatment: cefalexin (cephalexin) for infection, rash macular; steroid cream (unknown) for rash, macular rash; not reported for rest of the events.Outcome: recovered/resolved for ankle became infected; unknown for the event rash erythematous, autoimmune disorder recovering/resolving for rest of the events.A product technical complaint (ptc) was initiated on 24-nov-2022 for synvisc one (batch number: unknown) with global ptc number (b)(4).The sample status was not available.The ptc was set in process.Upon internal review on 24-nov-2022 case id (b)(4) (be deleted) was identified to be duplicate of (b)(4) (to be retained).Hence, all the information from the case (b)(4) (to be deleted) has been merged in case (b)(4).Additional events rash erythematous and autoimmune disorder was added.Ptc number and strength was also added.Additional information was received on 29-nov-2022 from the patient.Concurrent condition added.Text amended accordingly.
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Manufacturer Narrative
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Sanofi company comment for follow-up dated 24-nov-2022.Follow up information received does not change prior case assessment this case involves a 79 years old female patient who was treated with medical device hylan g-f 20, sodium hyaluronate [synvisc one] and the patient had rash (lesions) on all their limbs, particularly on the leg of the injection/first lesion appeared toward the end of (b)(6), on their right ankle below the knee injected, grew to the size of $2 coin over months and series of red dots appeared on their lower right leg overnight/spread to their arms, especially to their right hand, which required intervention with steroid usage, an autoimmune response, and overnight in (b)(6) suddenly had 10 red dots on my lower leg, and they grew and then developed into the same lesions as the others and responded identical in appearance.Based on limited information provided, causal role of suspect product cannot be excluded.Case will be re-evaluated post further update on the patients past drug history, concomitant medications.
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Event Description
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Series of red dots appeared on their lower right leg overnight/spread to their arms, especially to their right hand [red spotty rash].Rash (lesions) on all their limbs, particularly on the leg of the injection/first lesion appeared toward the end of (b)(6), on their right ankle below the knee injected, grew to the size of $2 coin over months, unexplained body rash about 8 months ago [rash] an autoimmune response [autoimmune disorder nos] overnight in (b)(6) suddenly had 10 red dots on my lower leg, and they grew and then developed into the same lesions as the others and responded identical in appearance [red rash] spread to the roof of their mouth, which made speaking and eating difficult [speech impairment nos] spread to the roof of their mouth, which made speaking and eating difficult [unable to eat] oozing clear liquid [skin oozing] ankle became infected [localised infection] sometimes bleeding [skin bleeding] inflammatory response [inflammatory reaction].Case narrative: initial information received on 15-nov-2022 regarding an unsolicited valid social media serious case received from a consumer from (b)(6).This case involves a 79 years old female patient who was treated with medical device hylan g-f 20, sodium hyaluronate [synvisc one]and the rash spread to the roof of their mouth, which made speaking and eating difficult, rash (lesions) on all their limbs, particularly on the leg of the injection/first lesion appeared toward the end of (b)(6), on their right ankle below the knee injected, grew to the size of $2 coin over months, oozing clear liquid, series of red dots appeared on their lower right leg overnight/spread to their arms, especially to their right hand, ankle became infected, sometimes bleeding and inflammatory response., an autoimmune response, and overnight in (b)(6) suddenly had 10 red dots on my lower leg, and they grew and then developed into the same lesions as the others and responded identical in appearance.The patient had no medical history, risk factor.The past medical treatment(s), vaccination(s) and family history were not provided.The patient was highly allergic to metals (nickel and cobalt) in a knee replacement (ongoing).On (b)(6) 2022, the patient received synvisc one injection dosage 6 ml once having the strength 48mg/6ml (lot, route- unknown) for arthritis and wear.Information on batch number was requested.Since an unknown date in (b)(6) 2022, after few days, patient had a rash (lesions) on all their limbs, particularly on the leg of the injection (rash) (intervention required), over a period of 8 months.The first lesion appeared toward the end of march, on their right ankle below the knee injected.It did not heal and grew to the size of $2 coin over months.Patient was sent to a cancer clinic for analysis but the cancer test was negative.On an unknown date in (b)(6) 2022, after 4 months approximately, during a terrible heat wave, a series of red dots appeared on their lower right leg overnight (rash macular) (intervention required), they grew in the same pattern, oozing clear liquid (skin weeping), sometimes bleeding (skin haemorrhage).It spread to the roof of their mouth, which made speaking and eating difficult (speech disorder and eating disorder).Then spread to their arms, especially to their right hand.All this time the tests showed no infection except initially when their ankle became infected (infection) (onset: (b)(6) 2022 and latency: 4 months approximately).Antibiotics (cephalexin) cleared their ankle lesion and their mouth's.All indications since have suggested an inflammatory response (inflammation) (onset: (b)(6) 2022 and latency: 4 months approximately).Patient did not consider synvisc-one as a cause until a few weeks ago when they were considering another shot as the first one was helpful and stated that they were highly allergic to metals (nickel and cobalt) in a knee replacement.The rash/lesions were now healing, although perhaps half a dozen were small and emerging and a few larger ones were still active.It seemed to be responding to a powerful steroid cream.Patient thought that perhaps whatever was causing this reaction in their system was lessening over time.Patient was going to see their doctor on the (b)(6) 2022.The healthcare professional was unaware of the skin condition so patient asked to wait to contact him until after they have seen him.Patient had decided not to have a second injection of the uncertainty about the cause.After a latency of few days approximately,patient received in injection on (b)(6) 2022 in r(right) knee.First lesion appeared a few days later on my r ankle, then it grew to a toney sized mark.Went for cancer tests, and they were negative.Lesions then started on the roof of my mouth, and overnight in (b)(6) suddenly had 10 red dots on my lower leg (rash erythematous) (intervention required), and they grew and then developed into the same lesions as the others and responded identical in appearance.Then since (b)(6) it spread to my other leg, and thigh and hip and upper back.Then became severe on my arms and especially on my r hand (rash) (intervention required).Patient had 2 biopsies and 2 swabs and they indicated an autoimmune response (autoimmune disorder) (medically significant).She was taking steroid and cream presently.Action taken: not applicable for all events.Corrective treatment: cefalexin (cephalexin) for infection, rash macular; steroid cream (unknown) for rash, macular rash; not reported for rest of the events.Outcome: recovered/resolved for ankle became infected; unknown for the event rash erythematous, autoimmune disorder recovering/resolving for rest of the events.A product technical complaint (ptc) was initiated on 24-nov-2022 for synvisc one (batch number: unknown) with global ptc number (b)(4).The sample status was not available.The ptc was set in process.Upon internal review on 24-nov-2022 case id (b)(4) (be deleted) was identified to be duplicate of (b)(4) (to be retained).Hence, all the information from the case (b)(4) (to be deleted) has been merged in case (b)(4).Additional events rash erythematous and autoimmune disorder was added.Ptc number and strength was also added.
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Event Description
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An autoimmune response [autoimmune disorder nos] series of 10 red dots appeared on lower right leg overnight/grew, developed into same lesions as others/responded identical in appearance spread to other leg, thigh and hip, upper back/became severe on arms and especially on r hand [red spotty rash] rash (lesions) on all their limbs, particularly on the leg of the injection/first lesion appeared toward the end of march, on their right ankle below the knee injected, grew to the size of $2 coin over months, unexplained body rash [generalised rash] series of 10 red dots appeared on lower right leg overnight/grew, developed into same lesions as others/responded identical in appearance spread to other leg, thigh and hip, upper back/became severe on arms and especially on r hand [red rash] spread to the roof of their mouth, which made speaking and eating difficult [speech impairment nos] spread to the roof of their mouth, which made speaking and eating difficult [unable to eat] oozing clear liquid [skin oozing] ankle became infected [localised infection] sometimes bleeding [skin bleeding] inflammatory response [inflammatory reaction] lesions (rash) then started/spread on the roof of her mouth [rash mouth] case narrative: initial information was received on (b)(6) 2022 regarding an unsolicited valid social media serious case from a consumer from canada.This case involves a (b)(6) years old female patient who was treated with medical device hylan g-f 20, sodium hyaluronate [synvisc one] and an autoimmune response; series of 10 red dots appeared on lower right leg overnight/grew, developed into same lesions as others/responded identical in appearance spread to other leg, thigh and hip, upper back/became severe on arms and especially on r hand; rash (lesions) on all their limbs, particularly on the leg of the injection/first lesion appeared toward the end of march, on their right ankle below the knee injected, grew to the size of $2 coin over months, unexplained body rash; spread to the roof of their mouth, which made speaking and eating difficult, oozing clear liquid, ankle became infected, sometimes bleeding, inflammatory response and lesions (rash) then started/spread on the roof of her mouth.The patient had no medical history, risk factor.The past medical treatment(s), vaccination(s) and family history were not provided.The patient was highly allergic to metals (nickel and cobalt) which are used in a knee replacement (ongoing).Concurrent condition included celiac disease.On (b)(6) 2022, the patient received synvisc one injection in r (right) knee at dose of 6 ml once via intra-articular route (strength 48mg/6ml) (lot, expiry date, route- unknown) for arthritis and wear.Information on batch number was requested.Toward the end of (b)(6) 2022, after a latency of few days, first lesion appeared on her right ankle, below the knee injected.It did not heal and grew to the size of $2 coin/toney sized mark over months.Patient was sent to a cancer clinic for analysis but the cancer test was negative.Since an unknown date in (b)(6) 2022, after few days, patient had a rash (lesions) on all their limbs, particularly on the leg of the injection (rash) (intervention required).On an unknown date in (b)(6) 2022 (overnight), after 4 months approximately, during a terrible heat wave, a series of 10 red dots appeared on their lower right leg (rash macular, rash erythematous) (intervention required), they grew and developed into the same lesions as others, in the same pattern/responded identical in appearance, oozing clear liquid (skin weeping), sometimes bleeding (skin haemorrhage).Then spread to their arms, especially to their right hand.Lesions then started/spread on the roof of her mouth (oral mucosal eruption; after 4 months approximately), which made speaking and eating difficult (speech disorder and eating disorder).All this time the tests showed no infection except initially when their ankle became infected (infection) (onset: (b)(6) 2022 and latency: 4 months approximately).Antibiotics (cephalexin) cleared their ankle lesion and their mouth's.All indications since have suggested an inflammatory response (inflammation) (onset: (b)(6) 2022 and latency: 4 months approximately).Then since (b)(6), it spread to her other leg, and thigh and hip and upper back.Then spread/became severe on her arms and especially on her r hand (rash) (intervention required).Patient had 2 biopsies and 2 swabs and they indicated an autoimmune response (autoimmune disorder) (medically significant).She was taking steroid and cream presently.Patient did not consider synvisc-one as a cause until a few weeks ago when they were considering another shot as the first one was helpful and stated that they were highly allergic to metals (nickel and cobalt) in a knee replacement.The rash/lesions were now healing, although perhaps half a dozen were small and emerging and a few larger ones were still active.It seemed to be responding to a powerful steroid cream.Patient thought that perhaps whatever was causing this reaction in their system was lessening over time.Patient had inquired about the ingredients of synvisc-one on (b)(6) 2022 and were wondering if it contained gluten as they had celiac disease.Patient was going to see their doctor on the (b)(6) 2022.The healthcare professional was unaware of the skin condition, so patient asked to wait to contact him until after they have seen him.Patient had decided not to have a second injection due to the uncertainty about the cause.Action taken: not applicable for all events corrective treatment: cefalexin (cephalexin) for oral mucosal eruption, localized infection, rash macular, rash, rash erythematous; steroid cream (unknown) for rash macular, rash, rash erythematous; not reported for rest of the events outcome: recovered for ankle became infected and oral mucosal eruption; unknown for autoimmune disorder recovering/resolving for rest of the events a product technical complaint (ptc) was initiated on (b)(6) 2022 for synvisc one (batch number: unknown) with global ptc number (b)(4).The sample status was not available.Ptc stated: product initially entered as synvisc updated product tab to synvisc one - (dp (b)(6) 2022).Based on the complaint from intake team, there is no quality related defect that would pose as a malfunction.- (dp (b)(6) 2022) the product lot number was not provided; therefore, a batch record review is not possible.Based on the lack of information provided, no capa (corrective and preventive action) is required.It is the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result is identified and mitigated through the ncr (non-conformance) process.Sanofi global pharmacovigilance and epidemiology continuously monitors adverse event reports with or without lot numbers, and assesses possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals.This review has not indicated any safety issue.Sanofi will continue to monitor complaints and trending to determine if a capa is required.The final investigation was completed on (b)(6) 2022 with summarized conclusion as no assessment possible.A product technical complaint (ptc) was initiated on (b)(6) 2022 for synvisc one (batch number: unknown) with global ptc number (b)(4).The sample status was not received and the ptc stated: defect class has been changed to ii - (dp (b)(6) 2022).Based on the complaint from intake team, there was no quality related defect that would pose as a malfunction.Sanofi global pharmacovigilance and epidemiology continuously monitors adverse event reports with or without lot numbers, and assesses possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals.(dp (b)(6) 2022).The product lot number was not provided; therefore, a batch record review was not possible.Based on the lack of information provided, no capa was required.It was the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result was identified and mitigated through the ncr process.Sanofi will continue to monitor complaints and trending to determine if a capa was required.The final investigation was completed on 22-dec-2022 with summarized conclusion as no assessment possible upon internal review on (b)(6) 2022 case id (b)(4) (be deleted) was identified to be duplicate of (b)(4) (to be retained).Hence, all the information from the case (b)(4) (to be deleted) has been merged in case (b)(4).Additional events rash erythematous and autoimmune disorder was added.Ptc number and strength was also added.Additional information was received on (b)(6) 2022 from the patient.Concurrent condition added.Text amended accordingly.Additional information was received on (b)(6) 2022 from other healthcare professional (from quality department).Gptc results were received and added.Upon internal review, an event was added- lesions (rash) then started/spread on the roof of her mouth.Text was amended accordingly.Additional information was received on (b)(6) 2022 from the quality department.Ptc details was added.
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Event Description
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An autoimmune response [autoimmune disorder nos].Series of 10 red dots appeared on lower right leg overnight/grew, developed into same lesions as others/responded identical in appearance spread to other leg, thigh and hip, upper back/became severe on arms and especially on r hand [red spotty rash].Rash (lesions) on all their limbs, particularly on the leg of the injection/first lesion appeared toward the end on (b)(6), on their right ankle below the knee injected, grew to the size of $2 coin over months, unexplained body rash [generalised rash].Spread to the roof of their mouth, which made speaking and eating difficult [speech impairment nos].Spread to the roof of their mouth, which made speaking and eating difficult [unable to eat].Oozing clear liquid [skin oozing].Ankle became infected [localised infection].Sometimes bleeding [skin bleeding].Inflammatory response [inflammatory reaction].Lesions (rash) then started/spread on the roof of her mouth [rash mouth].Case narrative: initial information was received on 15-nov-2022 regarding an unsolicited valid social media serious case from a consumer from canada.This case involves a 79 years old female patient who was treated with medical device hylan g-f 20, sodium hyaluronate [synvisc one] and an autoimmune response; series of 10 red dots appeared on lower right leg overnight/grew, developed into same lesions as others/responded identical in appearance spread to other leg, thigh and hip, upper back/became severe on arms and especially on r hand; rash (lesions) on all their limbs, particularly on the leg of the injection/first lesion appeared toward the end of march, on their right ankle below the knee injected, grew to the size of $2 coin over months, unexplained body rash; spread to the roof of their mouth, which made speaking and eating difficult, oozing clear liquid, ankle became infected, sometimes bleeding, inflammatory response and lesions (rash) then started/spread on the roof of her mouth.The patient had no medical history, risk factor.The past medical treatment(s), vaccination(s) and family history were not provided.The patient was highly allergic to metals (nickel and cobalt) which are used in a knee replacement (ongoing).Concurrent condition included celiac disease.On (b)(6) 2022, the patient received synvisc one injection in r (right) knee at dose of 6 ml once via intra-articular route (strength 48mg/6ml) for arthritis and wear.Information on batch number was requested.Toward the end on (b)(6) 2022, after a latency of few days, first lesion appeared on her right ankle, below the knee injected.It did not heal and grew to the size of $2 coin/toney sized mark over months.Patient was sent to a cancer clinic for analysis but the cancer test was negative.Since an unknown date on (b)(6) 2022, after few days, patient had a rash (lesions) on all their limbs, particularly on the leg of the injection (rash) (intervention required).On an unknown date on (b)(6) 2022 (overnight), after 4 months approximately, during a terrible heat wave, a series of 10 red dots appeared on their lower right leg (rash macular, rash erythematous) (intervention required), they grew and developed into the same lesions as others, in the same pattern/responded identical in appearance, oozing clear liquid (skin weeping), sometimes bleeding (skin haemorrhage).Then spread to their arms, especially to their right hand.Lesions then started/spread on the roof of her mouth (oral mucosal eruption; after 4 months approximately), which made speaking and eating difficult (speech disorder and eating disorder).All this time the tests showed no infection except initially when their ankle became infected (infection) (onset: on (b)(6) 2022 and latency: 4 months approximately).Antibiotics (cephalexin) cleared their ankle lesion and their mouth's.All indications since have suggested an inflammatory response (inflammation) (onset: on (b)(6) 2022 and latency: 4 months approximately).Then since on (b)(6), it spread to her other leg, and thigh and hip and upper back.Then spread/became severe on her arms and especially on her r hand (rash) (intervention required).Patient had 2 biopsies and 2 swabs and they indicated an autoimmune response (autoimmune disorder) (medically significant).She was taking steroid and cream presently.Patient did not consider synvisc-one as a cause until a few weeks ago when they were considering another shot as the first one was helpful and stated that they were highly allergic to metals (nickel and cobalt) in a knee replacement.The rash/lesions were now healing, although perhaps half a dozen were small and emerging and a few larger ones were still active.It seemed to be responding to a powerful steroid cream.Patient thought that perhaps whatever was causing this reaction in their system was lessening over time.Patient had inquired about the ingredients of synvisc-one on (b)(6) 2022 and were wondering if it contained gluten as they had celiac disease.Patient was going to see their doctor on (b)(6) 2022.The healthcare professional was unaware of the skin condition, so patient asked to wait to contact him until after they have seen him.Patient had decided not to have a second injection due to the uncertainty about the cause.Action taken: not applicable for all events.Corrective treatment: cefalexin (cephalexin) for oral mucosal eruption, localized infection, rash macular, rash, rash erythematous; steroid cream (unknown) for rash macular, rash, rash erythematous; not reported for rest of the events.Outcome: recovered for ankle became infected and oral mucosal eruption; unknown for autoimmune disorder recovering/resolving for rest of the events.A product technical complaint (ptc) was initiated on 15-nov-2022 for synvisc one with global ptc number: 100277657.The sample status was not available.Ptc stated: product initially entered as synvisc updated product tab to synvisc one (dp 28nov22).Based on the complaint from intake team, there is no quality related defect that would pose as a malfunction.(dp 05dec22).The product lot number was not provided; therefore, a batch record review is not possible.Based on the lack of information provided, no capa (corrective and preventive action) is required.It is the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result is identified and mitigated through the ncr (non-conformance) process.Sanofi global pharmacovigilance and epidemiology continuously monitors adverse event reports with or without lot numbers, and assesses possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals.This review has not indicated any safety issue.Sanofi will continue to monitor complaints and trending to determine if a capa is required.The final investigation was completed on 06-dec-2022 with summarized conclusion as no assessment possible.Upon internal review on 24-nov-2022 case id: (b)(4) (be deleted) was identified to be duplicate of (b)(4) (to be retained).Hence, all the information from the case: (b)(4) (to be deleted) has been merged in case: (b)(4).Additional events rash erythematous and autoimmune disorder was added.Ptc number and strength was also added.Additional information was received on 29-nov-2022 from the patient.Concurrent condition added.Text amended accordingly.Additional information was received on 06-dec-2022 from other healthcare professional (from quality department).Gptc results were received and added.Upon internal review, an event was added- lesions (rash) then started/spread on the roof of her mouth.Text was amended accordingly.
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