| Lot Number 156100 |
| Device Problem
Nonstandard Device (1420)
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| Patient Problems
Diarrhea (1811); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Hot Flashes/Flushes (2153); Tingling (2171); Injury (2348); Reaction, Injection Site (2442); No Code Available (3191)
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| Event Date 11/01/2002 |
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).On (b)(6)2011, the fda granted the permission for the manufacturer fidia (b)(4) to submit a single mdr for adverse events that involve medical devices manufactured by fidia (b)(4) and imported into the usa by fidia pharma usa, inc.As a consequence, fidia (b)(4) (the manufacturer) is submitting this report even on behalf of fidia pharma usa inc.(the importer).The present mdr report satisfies the reporting obligations for both companies.The spontaneous case from a patient, not medically confirmed, was received from fidia pharma usa (the fidia's partner in usa).The report was initially received on date (b)(6)2016 and the case was assessed as non serious.On (b)(6) 2016, fidia received notification of the case from the fda (report number: mw5064183) and the case has been upgraded as serious, due to other medically important conditions.The adverse events "injection site joint discomfort, injection site joint movement impairment, tingling, sensation of heat, injury to unspecified blood vessel of lower extremity, esophageal reflux, diarrhea and indigestion " are unexpected for hyalgan, while "itching and knee pain" are expected for hyalgan.The relationship between the reactions and the administration of hyalgan is deemed as being "probable", except for "esophageal reflux, diarrhea and indigestion" that is deemed as being "possible".Follow-up ((b)(6) 2016): from the follow-up information the relationship between the events "esophageal reflux, diarrhea and indigestion" and the administration of hyalgan is deemed as being "not related", because the patient's physician did not attribute the gastrointestinal symptoms to hyalgan.Furthermore, it was added the event "off label use" and the event "sensation of heat" was updated as listed.No further information was available.Device was not available.
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Event Description
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This spontaneous, non-serious adverse event was reported by a (b)(6) -year-old female patient.On (b)(6) 2002 the patient was started on hyalgan of an unknown dose, weekly for 3 injections, for an unknown indication of the knee.On (b)(6) 2002 the patient completed her first series of hyalgan.On (b)(6) 2002 the patient began a second series of hyalgan of an unknown dose for 5 injections which were completed on (b)(6) 2002.In 2002 the patient saw some reduction in pain following hyalgan but did not have full mobility and felt like there was a "jam" in her knee.The patient iced her knee and the mobility issues resolved.On an unknown date in 2014 the patient received synvisc-one for an unknown indication and her knee blew up.On an unknown date the patient was diagnosed with patellofemoral pain syndrome.On (b)(6) 2016 the patient was restarted on hyalgan, one syringe in the left knee, once weekly for patellofemoral pain syndrome, which is an off-label indication (b)(4).On (b)(6) 2016 the patient received hyalgan injections in the left and right knee and within 30 minutes experienced a strange tingling, heat (b)(4), and intense itching in the leg above the left knee; the right knee was unaffected.The patient also experienced burst blood vessels above the left knee(b)(4) and the area turned blue and purple for which the patient applied ice and took ibuprofen.On the night of (b)(6) 2016 the patient experienced massive reflux(b)(4), indigestion(b)(4), the runs, and intense knee pain at a level of 10/10.The patient drank a large amount of water in an attempt to flush out the hyalgan, and the reflux, indigestion, and the runs resolved that night.The tingling, heat, and intense itching also resolved but she began experiencing discomfort and pain in the area above the left knee that was affected.On (b)(6) 2016 the patient contacted her physician's office and explained her reactions.On an unknown date, 2-3 days after the hyalgan injection, the intense knee pain resolved, however, the burst blood vessels remained and the area remained dark blue and purple resembling a "metro map".On (b)(6) 2016 the patient visited her physician who told her that he did not believe these reactions were related to hyalgan, and was ready to give her next hyalgan injection, which the patient refused.The patient made an appointment with the vascular surgeon and would like to submit pictures.The patient wondered if the reactions were related to a certain batch of hyalgan.The lot numbers were 156100 and 150900 and belong to the hyalgan received in 2016.The expiration dates were unknown.As of (b)(6) 2016 the patient was no longer using hyalgan or synvisc-one.The outcome of not having full mobility, tinging, heat, intense itching, reflux, indigestion, the runs, and intense knee pain was resolved.The outcome of her right knee blowing up like a balloon, jam in knee, intense knee pain, and off-label use for patellofemoral pain syndrome was unknown.The outcome of patellofemoral pain syndrome, blood vessels burst, purple and blue discoloration, discomfort and pain above the knee was ongoing.Follow-up ((b)(6) 2016): recorded information by (b)(6) from fda event report.Received at fidia pharma usa (b)(6) 2016 report number: mw5064183 / date fda received: (b)(6) 2016 / date fda added: (b)(6) 2016 08:18:06:00.Event information: event date : (b)(6) 2016.Report date: (b)(6) 2016.Event report type : serious injury.Adverse event : y.Event outcome : other serious (important medical event).Problem : n.Reporter occupation patient.Device information: product code : acid, hyaluronic, intraarticular (moz).Brand : hyalgan.Device type : hyalgan.Lot #: 150900.Product code : acid, hyaluronic, intraarticular (moz).Brand : hyalgan.Device type : hyalgan.Lot # : 156100.Recorded information by (b)(6) from fda event report.Received at fidia pharma usa (b)(6) 2016.Adverse reaction to hyalgan knee injections lot #156100, lot #150900 chronology: (b)(6)" 1st injection in left knee by dr.(b)(6), office.No reaction to this injection in the following days.On (b)(6)" 2nd injection in left knee and first injection in right knee within minutes of the injections the left thigh above the knee began to tingle, [?]heat' and itch with a burning sensation.The veins of the left thigh had turned dark purple and brown.The tingling and discomfort continued for several hours on the left side.The veins are permanently discolored.The night of (b)(6) i experienced a lot of reflux, indigestion and diarrhea.I also had massive knee pain in both legs; the increment in bi-lateral knee pain continued for three days.On (b)(6) i called dr.(b)(6) office and reported my reactions to the injections.I requested a call back from the doctor but did not receive one.I contacted dr.(b)(6) office and requested a copy of the "c" ticket to determine which lot had been used in the 2nd injection in the left knee but this info was not provided on (b)(6).I called the fda and spoke to (b)(6); we began a report about this allergic response.On (b)(6) i called dr.(b)(6) office and (b)(6) gave me the lot numbers of the injections.I also write ms.(b)6) of the (b)(6) office and requested the "c" copy but have no response to that request so far on (b)(6).F/u visit with dr.(b)(6) who assured me that the broken blood vessels and reaction had nothing to do with the 2nd injection of hyalgan in my left knee.He suggests it is psychological and is confident he can reinject both knees.I respond [?]no' that following the horrible aspect of the veins in my left thigh i do not wish to risk further damage.On (b)(6) i contact (b)(4), the producer of hyalgan and learned the injections were produced in (b)(4).Ms.(b)(6) recommends i contact their medical info line.I spoke to (b)(6) who took a full report, case # (b)(4).I told (b)(6) that when the next rep from (b)(4) calls i would like to submit this report along with a photo of the damaged thigh.(b)(6) tells me i will be hearing from another rep from(b)(4).Note dr.(b)(6) office still has 7 remaining hyalgan injections that were approved by (b)(6) for use on my knees.A total of 10 injections, 5 per knee.A total of 3 were used.Dates of use (b)(6) 2016.Diagnosis or reason for use: to treat pain in post patellar femoral syndrome.Concomitant medical products ibuprofen, multi vitamin, soy supplement, baby aspirin.Initial reporter information name : (b)(6).Also reported to : manufacturer: user facility: n distributor/importer: phone : (b)(6) occupation : patient.Not releasable : n.Follow-up was received on (b)(6) 2016 by (b)(4) from fidia: patient reported that her pain level of a 4 was prior to the hyalgan injection.The reported diagnosis of patellofemoral pain syndrome was according to the patient.The treating physician's information was not provided by the patient and it is unknown if knew osteoarthritis was clinically diagnosed.The patient attributed her symptoms to the hyalgan but her physician did not attribute her gastrointestinal symptoms to the hyalgan.The patient noted that no intervention was required following the onset of symptoms.On (b)(6) 2016 the patient reported that she had an unknown test conducted on her veins on an unknown date, and will be meeting with a vascular surgeon on (b)(6) 2016 regarding issues with her blood vessels.According to fda report, this case is now considered serious and will be reported according to the current regulation.
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Manufacturer Narrative
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(b)(4).The spontaneous case from a patient, not medically confirmed, was received from fidia pharma usa (the fidia's partner in usa).The report was initially received on date 05 august 2016 and the case was assessed as non serious.On 29 august 2016, fidia received notification of the case from the fda (report number: mw5064183) and the case has been upgraded as serious, due to other medically important conditions.The adverse events "injection site joint discomfort, injection site joint movement impairment, tingling, sensation of heat, injury to unspecified blood vessel of lower extremity, esophageal reflux, diarrhea and indigestion" are unexpected for hyalgan, while "itching and knee pain" are expected for hyalgan.The relationship between the reactions and the administration of hyalgan is deemed as being "probable", except for "esophageal reflux, diarrhea and indigestion" that is deemed as being "possible".Follow-up (06-sep-2016): from the follow-up information the relationship between the events "esophageal reflux, diarrhea and indigestion" and the administration of hyalgan is deemed as being "not related", because the patient's physician did not attribute the gastrointestinal symptoms to hyalgan.Furthermore, it was added the event "off label use" and the event "sensation of heat" was updated as listed.No further information was available.Follow-up (22-sep-2016): following the follow-up are included the new events "allergic reaction and permanent injury" that are unlisted for hyalgan.The relationship between these reactions and the administration of hyalgan is deemed as being "unassessable".The company is performing an adequate investigation on the batches of the product involved in the occurrence.A further fu has been requested and if new safety information will be available on the case it will be communicated.Device was not available.
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Event Description
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This spontaneous, non-serious adverse event was reported by a (b)(6) female patient.On (b)(6) 2002 the patient was started on hyalgan of an unknown dose, weekly for 3 injections, for an unknown indication of the knee.On (b)(6) 2002 the patient completed her first series of hyalgan.On (b)(6) 2002 the patient began a second series of hyalgan of an unknown dose for 5 injections which were completed on (b)(6) 2002.In 2002 the patient saw some reduction in pain following hyalgan but did not have full mobility and felt like there was a "jam" in her knee.The patient iced her knee and the mobility issues resolved.On an unknown date in 2014 the patient received synvisc-one for an unknown indication and her knee blew up.On an unknown date the patient was diagnosed with patellofemoral pain syndrome.On (b)(6) 2016 the patient was restarted on hyalgan, one syringe in the left knee, once weekly for patellofemoral pain syndrome, which is an off-label indication.On (b)(6) 2016 the patient received hyalgan injections in the left and right knee and within 30 minutes experienced a strange tingling, heat, and intense itching in the leg above the left knee; the right knee was unaffected.The patient also experienced burst blood vessels above the left knee and the area turned blue and purple for which the patient applied ice and took ibuprofen.On the night of (b)(6) 2016 the patient experienced massive reflux, indigestion, the runs, and intense knee pain at a level of 10/10.The patient drank a large amount of water in an attempt to flush out the hyalgan, and the reflux, indigestion, and the runs resolved that night.The tingling, heat, and intense itching also resolved but she began experiencing discomfort and pain in the area above the left knee that was affected.On (b)(6) 2016 the patient contacted her physician's office and explained her reactions.On an unknown date, 2-3 days after the hyalgan injection, the intense knee pain resolved, however, the burst blood vessels remained and the area remained dark blue and purple resembling a "metro map".On (b)(6) 2016 the patient visited her physician who told her that he did not believe these reactions were related to hyalgan, and was ready to give her next hyalgan injection, which the patient refused.The patient made an appointment with the vascular surgeon and would like to submit pictures.The patient wondered if the reactions were related to a certain batch of hyalgan.The lot numbers were 156100 and 150900 and belong to the hyalgan received in 2016.The expiration dates were unknown.As of (b)(6) 2016 the patient was no longer using hyalgan or synvisc-one.The outcome of not having full mobility, tinging, heat, intense itching, reflux, indigestion, the runs, and intense knee pain was resolved.The outcome of her right knee blowing up like a balloon, jam in knee, intense knee pain, and off-label use for patellofemoral pain syndrome was unknown.The outcome of patellofemoral pain syndrome, blood vessels burst, purple and blue discoloration, discomfort and pain above the knee was ongoing.Follow-up (29-aug-2016): recorded information by (b)(4) from fda event report.Received at fidia pharma usa 29-aug-2016.Report number: mw5064183 / date fda received: 16-aug-2016 / date fda added: 19-aug-2016 08:18:06:00.Event information: event date: (b)(6) 2016.Report date: 19-aug-2016.Event report type: serious injury.Adverse event: y.Event outcome: other serious (important medical event).Problem: n.Reporter occupation: patient.Device information: product code: acid, hyaluronic, intraarticular (moz).Brand: hyalgan.Device type: hyalgan.Lot #: 150900; product code: acid, hyaluronic, intraarticular (moz).Brand: hyalgan.Device type: hyalgan.Lot #: 156100, recorded information by (b)(4) from fda event report.Received at fidia pharma usa 29-aug-2016.Adverse reaction to hyalgan knee injections lot #156100, lot #150900 chronology: (b)(6)" 1st injection in left knee by dr.(b)(6), office.No reaction to this injection in the following days.On (b)(6)" 2nd injection in left knee and first injection in right knee within minutes of the injections the left thigh above the knee began to tingle, [?]heat' and itch with a burning sensation.The veins of the left thigh had turned dark purple and brown.The tingling and discomfort continued for several hours on the left side.The veins are permanently discolored.The night of (b)(6) i experienced a lot of reflux, indigestion and diarrhea.I also had massive knee pain in both legs; the increment in bi-lateal knee pain continued for three days.On (b)(6) i called dr.(b)(6) office and reported my reactions to the injections.I requested a call back from the doctor but did not receive one.I contacted dr.(b)(6) office and requested a copy of the "c" ticket to determine which lot had been used in the 2nd injection in the left knee but this info was not provided on (b)(6).I called the fda and spoke to (b)(6); we began a report about this allergic response.On (b)(6) i called dr.(b)(6) office and (b)(6) gave me the lot numbers of the injections.I also write ms.(b)6) of the (b)(6) office and requested the "c" copy but have no response to that request so far on (b)(6).F/u visit with dr.(b)(6) who assured me that the broken blood vessels and reaction had nothing to do with the 2nd injection of hyalgan in my left knee.He suggests it is psychological and is confident he can reinject both knees.I respond [?]no' that following the horrible aspect of the veins in my left thigh i do not wish to risk further damage.On (b)(6) i contact (b)(4), the producer of hyalgan and learned the injections were produced in (b)(4).Ms.(b)(6) recommends i contact their medical info line.I spoke to (b)(6) who took a full report, case # (b)(4).I told (b)(6) that when the next rep from (b)(4) calls i would like to submit this report along with a photo of the damaged thigh.(b)(6) tells me i will be hearing from another rep from(b)(4).Note dr.(b)(6) office still has 7 remaining hyalgan injections that were approved by (b)(6) for use on my knees.A total of 10 injections, 5 per knee.A total of 3 were used.Dates of use (b)(6) 2016.Diagnosis or reason for use: to treat pain in post patellar femoral syndrome.Concomitant medical products: ibuprofen, multi vitamin, soy supplement, baby aspirin.(b)(6).Follow-up was received on 06-sep-2016 by (b)(4) from fidia: patient reported that her pain level of a 4 was prior to the hyalgan injection.The reported diagnosis of patellofemoral pain syndrome was according to the patient.The treating physician's information was not provided by the patient and it is unknown if knew osteoarthritis was clinically diagnosed.The patient attributed her symptoms to the hyalgan but her physician did not attribute her gastrointestinal symptoms to the hyalgan.The patient noted that no intervention was required following the onset of symptoms.On (b)(6) 2016 the patient reported that she had an unknown test conducted on her veins on an unknown date, and will be meeting with a vascular surgeon on (b)(6) 2016 regarding issues with her blood vessels.According to fda report, this case is now considered serious and will be reported according to the current regulation.Follow-up received on 22-sep-2016: patient reported that she developed permanent damage after hyalgan treatment.She attributes this to either an allergic reaction or a faulty lot number.The hyalgan was injected by an experienced orthopedic surgeon who felt that her reaction could have been psychological, but the damage in her legs is not psychological.The patient stated that her reaction is definitely related to hyalgan.The patient visited a vascular surgeon and a doppler sonogram was performed.Results from the doppler sonogram received in (b)(6) 2016 revealed no blockage; therefore, the patient stated that her reaction was not related to any blockage in her leg.The patient stated that the permanent damage will cost her (b)(6) to treat and she will never have hyalgan injected again.
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