MAUDE Adverse Event Report: GENZYME CORPORATION(RIDGEFIELD) SYNVISC ONE; MOZ

Lot Number ARSL009A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Rash (2033); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/17/2021

Event Type  Injury  

Event Description

Red dots on the head on the neck, face and chest, spread to her back, abdomen and lower limbs [red blotches].Case narrative: initial information received on 14-apr-2021, regarding an unsolicited valid- serious case received from a non-healthcare professional.Country: (b)(6).This case involves an unknown age female patient who experienced red dots on the head on the neck, face and chest, spread to her back, abdomen and lower limbs while being treated with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one] and covid-19 vaccine.The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On (b)(6) 2021, hylan g-f 20, sodium hyaluronate was purchased.On (b)(6) 2021, the patient received treatment with hylan g-f 20, sodium hyaluronate once in knee (dose, route, formulation and batch number unknown) (information on batch number was requested) for unknown indication and it was guaranteed that the product was kept at room temperature until the date of the infiltration.On (b)(6) 2021, patient received covid-19 vaccine (pfizer).On (b)(6) 2021, one day later, after latency of 9 days, patient started having allergic reactions, such as red dots on the head on the neck, face and chest which after five days spread to her back, abdomen and lower limbs (rash macular; seriousness criteria: hospitalization).As of today, patient was hospitalized (since unknown date in 2021) and being monitored by the medical team, who despite the effects, could not see that it was related to the infiltration of the knee, but perhaps related to the vaccine.Reporter had a doubt, about the composition of synvisc one that could, perhaps created an allergic reaction.It was also reported that patient would be discharged from the hospital on monday, so by then she would have a medical report in order to better clarify the clinical condition.Action taken: not applicable for both suspects (hylan g-f 20, sodium hyaluronate and covid-19 vaccine).It was not reported if the patient received a corrective treatment.At time of reporting, the outcome was unknown.

Event Description

Red dots on the head on the neck, face and chest, spread to her back, abdomen and lower limbs [red blotches].Case narrative: initial information was received from (b)(6) on 14-apr-2021 regarding an unsolicited valid serious case received from a non-healthcare professional.This case involves an unknown age female patient who experienced red dots on the head on the neck, face and chest, spread to her back, abdomen and lower limbs while being treated with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one] and covid-19 vaccine.The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On (b)(6) 2021, hylan g-f 20, sodium hyaluronate was purchased.On (b)(6) 2021, the patient received treatment with hylan g-f 20, sodium hyaluronate once in knee (dose, route, formulation, indication, and batch number unknown) (information on batch number was requested) and it was guaranteed that the product was kept at room temperature until the date of the infiltration.On (b)(6) 2021, patient received covid-19 vaccine (pfizer).On (b)(6) 2021, one day later, after latency of 9 days, patient started having allergic reactions, such as red dots on the head on the neck, face and chest which after five days spread to her back, abdomen and lower limbs (rash macular; seriousness criteria: hospitalization).As of today, patient was hospitalized (since unknown date in 2021) and being monitored by the medical team, who despite the effects, could not see that it was related to the infiltration of the knee, but perhaps related to the vaccine.Reporter had a doubt, about the composition of synvisc one that could, perhaps created an allergic reaction.It was also reported that patient would be discharged from the hospital on monday, so by then she would have a medical report in order to better clarify the clinical condition.Action taken: not applicable for both suspects (hylan g-f 20, sodium hyaluronate and covid-19 vaccine).It was not reported if the patient received a corrective treatment.At time of reporting, the outcome was unknown.A product technical complaint was initiated on 14-apr-2021 for synvisc one (lot number unknown) with global ptc number (b)(4).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 action preventive actions) 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 (full form not specified) 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 as to determine if a capa was required.Final investigation was completed on 23-apr-2021.Seriousness criteria: hospitalization and intervention required.Additional information was received on 23-apr-2021 from the other healthcare professional.Ptc results received and processed.Global ptc number was added.

Event Description

Red dots on the head on the neck, face and chest, spread to her back, abdomen and lower limbs [red blotches], vaccine will have potentiated an allergic reaction to another medication [allergic reaction], reaction was due to an interaction between some of the drugs which she usually takes and the vaccine against covid-19 [drug interaction potentiation].Case narrative: initial information was received from (b)(6) on 14-apr-2021 regarding an unsolicited valid serious case received from a non-healthcare professional.This case involves (b)(6) year old female patient who had reaction which was due to an interaction between some of the drugs which she usually takes and the vaccine against covid-19 while being treated with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one) and covid-19 vaccine.The patient's past medical treatment(s), vaccination(s) and family history were not provided.Patient was diagnosed with heart failure in (b)(6) 2020 and due to the same, patient regularly takes anticoagulants rivaroxaban (xarelto) and diuretics, which she was unable to specify which ones.Patient had no history of allergies, either to food or medication.On (b)(6) 2021, synvisc one was purchased.On (b)(6) 2021, the patient received treatment with synvisc one once in knee (dose, route, formulation, indication unknown, batch number: arsl009a) and it was guaranteed that the product was kept at room temperature until the date of the infiltration.On (b)(6) 2021, patient received covid-19 vaccine (comirnaty) from pfizer.On (b)(6) 2021, one day later, after latency of 9 days, patient started having allergic reactions, such as red dots on the head on the neck, face and chest which after five days spread to her back, abdomen and lower limbs (rash macular).The opinion of the doctors was that the reaction was due to an interaction between some of the drugs which she usually takes and the vaccine against covid-19 (potentiating drug interaction, onset: 2021, latency: unknown).The vaccine will have potentiated an allergic reaction to another medication (hypersensitivity), which they are still not sure what it was, but they are not related to the administration of synvisc one, so doctors have advised to temporarily stop taking it.Patient was hospitalized on (b)(6) 2021 for the reactions and was monitored by the medical team.Event of potentiating drug interaction and its symptoms assessed as serious due to hospitalization.Reporter had a doubt, about the composition of synvisc one that could, perhaps created an allergic reaction.Patient was discharged on (b)(6) 2021.At the moment doctors are looking forward to the second dose of the vaccine, which will be at the end of (b)(6).Action taken: not applicable for synvisc one and no action taken for covid-19 vaccine.It was not reported if the patient received a corrective treatment.At time of reporting, the outcome was recovered for events of potentiating drug interaction, hypersensitivity and unknown for rash macular.A product technical complaint was initiated on 14-apr-2021 for synvisc one (lot number unknown) with global ptc number (b)(4).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) was 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-conformances report) 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 as to determine if a capa was required.Final investigation was completed on 23-apr-2021.Additional information was received on 23-apr-2021 from the other healthcare professional.Ptc results received and processed.Global ptc number was added.Additional information was received on 28-apr-2021 from patient's son.Event of reaction was due to an interaction between some of the drugs which she usually takes and the vaccine against covid-19 was added with details.Medical history, concomitant medications and batch number for the suspect synvisc one was added.Clinical course updated.Text amended accordingly.

Event Description

Reaction was due to an interaction between some of the drugs which she usually takes and the vaccine against covid-19 [drug interaction potentiation], red dots on the head on the neck, face and chest, spread to her back, abdomen and lower limbs [red blotches], vaccine will have potentiated an allergic reaction to another medication [allergic reaction].Case narrative: initial information was received from (b)(6) on 14-apr-2021 regarding an unsolicited valid serious case received from a non-healthcare professional.This case involves (b)(6) year old female patient who had reaction which was due to an interaction between some of the drugs which she usually takes and the vaccine against covid-19 while being treated with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one) and covid-19 vaccine.The patient's past medical treatment(s), vaccination(s) and family history were not provided.Patient was diagnosed with heart failure in (b)(6) 2020 and due to the same, patient regularly takes anticoagulants rivaroxaban (xarelto) and diuretics, which she was unable to specify which ones.Patient had no history of allergies, either to food or medication.On (b)(6) 2021, synvisc one was purchased.On (b)(6) 2021, the patient received treatment with synvisc one once in knee (dose, route, formulation, indication unknown, batch number: arsl009a) and it was guaranteed that the product was kept at room temperature until the date of the infiltration.On (b)(6) 2021, patient received covid-19 vaccine (comirnaty) from pfizer.On (b)(6) 2021, one day later, after latency of 9 days, patient started having allergic reactions, such as red dots on the head on the neck, face and chest which after five days spread to her back, abdomen and lower limbs (rash macular).The opinion of the doctors was that the reaction was due to an interaction between some of the drugs which she usually takes and the vaccine against covid-19 (potentiating drug interaction, onset: 2021, latency: unknown).The vaccine will have potentiated an allergic reaction to another medication (hypersensitivity), which they are still not sure what it was, but they are not related to the administration of synvisc one, so doctors have advised to temporarily stop taking it.Patient was hospitalized on (b)(6) 2021 for the reactions and was monitored by the medical team.Event of potentiating drug interaction and its symptoms assessed as serious due to hospitalization.Reporter had a doubt, about the composition of synvisc one that could, perhaps created an allergic reaction.Patient was discharged on (b)(6) 2021.At the moment doctors are looking forward to the second dose of the vaccine, which will be at the end of (b)(6).Action taken: not applicable for synvisc one and no action taken for covid-19 vaccine.It was not reported if the patient received a corrective treatment.At time of reporting, the outcome was recovered for events of potentiating drug interaction, hypersensitivity and unknown for rash macular.A product technical complaint was initiated on 14-apr-2021 for synvisc one (lot number unknown) with global ptc number (b)(4).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) was 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-conformances report) 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 as to determine if a capa was required.Final investigation was completed on 23-apr-2021.Additional information was received on 23-apr-2021 from the other healthcare professional.Ptc results received and processed.Global ptc number was added.Additional information was received on 28-apr-2021 from patient's son.Event of reaction was due to an interaction between some of the drugs which she usually takes and the vaccine against covid-19 was added with details.Medical history, concomitant medications and batch number for the suspect synvisc one was added.Clinical course updated.Text amended accordingly.Based on information previously received, the following information have been amended: section 4.1 (c) (what further information do you intend in view of reaching final conclusion) of mir was updated.

Event Description

Reaction was due to an interaction between some of the drugs which she usually takes and the vaccine against covid-19 [drug interaction potentiation], red dots on the head on the neck, face and chest, spread to her back, abdomen and lower limbs [red blotches], vaccine will have potentiated an allergic reaction to another medication [allergic reaction].Case narrative: initial information was received from portugal on 14-apr-2021 regarding an unsolicited valid serious case received from a non-healthcare professional.This case involves (b)(6) year old female patient who had reaction which was due to an interaction between some of the drugs which she usually takes and the vaccine against covid-19 while being treated with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one) and covid-19 vaccine.The patient's past medical treatment(s), vaccination(s) and family history were not provided.Patient was diagnosed with heart failure in (b)(6) 2020 and due to the same, patient regularly takes anticoagulants rivaroxaban (xarelto) and diuretics, which she was unable to specify which ones.Patient had no history of allergies, either to food or medication.On (b)(6) 2021, synvisc one was purchased.On (b)(6) 2021, the patient received treatment with synvisc one once in knee (dose, route, formulation, indication unknown, batch number: arsl009a) and it was guaranteed that the product was kept at room temperature until the date of the infiltration.On (b)(6) 2021, patient received covid-19 vaccine (comirnaty) from pfizer for covid-19 vaccination.On (b)(6) 2021, one day later, after latency of 9 days, patient started having allergic reactions, such as red dots on the head on the neck, face and chest which after five days spread to her back, abdomen and lower limbs (rash macular).The opinion of the doctors was that the reaction was due to an interaction between some of the drugs which she usually takes and the vaccine against covid-19 (potentiating drug interaction, onset: 2021, latency: unknown).The vaccine will have potentiated an allergic reaction to another medication (hypersensitivity), which they are still not sure what it was, but they are not related to the administration of synvisc one, so doctors have advised to temporarily stop taking it.Patient was hospitalized on (b)(6) 2021 for the reactions and was monitored by the medical team.Event of potentiating drug interaction and its symptoms assessed as serious due to hospitalization.Reporter had a doubt, about the composition of synvisc one that could, perhaps created an allergic reaction.Patient was discharged on (b)(6) 2021.At the moment doctors are looking forward to the second dose of the vaccine, which will be at the end of (b)(6).Action taken: not applicable for synvisc one and no action taken for covid-19 vaccine.It was not reported if the patient received a corrective treatment.At time of reporting, the outcome was recovered for events of potentiating drug interaction, hypersensitivity and unknown for rash macular.A product technical complaint was initiated on 14-apr-2021 for synvisc one (lot number unknown) with global ptc number (b)(4).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) was 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-conformances report) 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 as to determine if a capa was required.Final investigation was completed on 23-apr-2021.Additional information was received on 23-apr-2021 from the other healthcare professional.Ptc results received and processed.Global ptc number was added.Additional information was received on 28-apr-2021 from patient's son.Event of reaction was due to an interaction between some of the drugs which she usually takes and the vaccine against covid-19 was added with details.Medical history, concomitant medications and batch number for the suspect synvisc one was added.Clinical course updated.Text amended accordingly.Based on information previously received, the following information have been amended: section 4.1 (c) (what further information do you intend in view of reaching final conclusion) of mir was updated.Upon internal review on 07-may-2021, based on information previously received, drug interaction was marked as yes for synvisc one and covid-19 vaccine.

Event Description

Reaction was due to an interaction between some of the drugs which she usually takes and the vaccine against covid-19 [drug interaction potentiation], red dots on the head on the neck, face and chest, spread to her back, abdomen and lower limbs [red blotches], vaccine will have potentiated an allergic reaction to another medication [allergic reaction].Case narrative: initial information was received from (b)(6) on 14-apr-2021 regarding an unsolicited valid serious case received from a non-healthcare professional.This case involves (b)(6) year old female patient who had reaction which was due to an interaction between some of the drugs which she usually takes and the vaccine against covid-19 while being treated with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one) and covid-19 vaccine.The patient's past medical treatment(s), vaccination(s) and family history were not provided.Patient was diagnosed with heart failure in (b)(6) 2020 and due to the same, patient regularly takes anticoagulants rivaroxaban (xarelto) and diuretics, which she was unable to specify which ones.Patient had no history of allergies, either to food or medication.On (b)(6) 2021, synvisc one was purchased.On (b)(6) 2021, the patient received treatment with synvisc one once in knee (dose, route, formulation, indication unknown, batch number: arsl009a, expiration date: jan-2023) and it was guaranteed that the product was kept at room temperature until the date of the infiltration.On (b)(6) 2021, patient received covid-19 vaccine (comirnaty) from pfizer for covid-19 vaccination.On (b)(6) 2021, one day later, after latency of 9 days, patient started having allergic reactions, such as red dots on the head on the neck, face and chest which after five days spread to her back, abdomen and lower limbs (rash macular).The opinion of the doctors was that the reaction was due to an interaction between some of the drugs which she usually takes and the vaccine against covid-19 (potentiating drug interaction, onset: 2021, latency: unknown).The vaccine will have potentiated an allergic reaction to another medication (hypersensitivity), which they are still not sure what it was, but they are not related to the administration of synvisc one, so doctors have advised to temporarily stop taking it.Patient was hospitalized on (b)(6) 2021 for the reactions and was monitored by the medical team.Event of potentiating drug interaction and its symptoms assessed as serious due to hospitalization.Reporter had a doubt, about the composition of synvisc one that could, perhaps created an allergic reaction.Patient was discharged on (b)(6) 2021.At the moment doctors are looking forward to the second dose of the vaccine, which will be at the end of (b)(6).Action taken: not applicable for synvisc one and no action taken for covid-19 vaccine.It was not reported if the patient received a corrective treatment.At time of reporting, the outcome was recovered for events of potentiating drug interaction, hypersensitivity and unknown for rash macular.A product technical complaint (ptc) was initiated on 14-apr-2021 for synvisc one.Batch number: arsl009a; comet compliant id number: (b)(4).The production and quality control documentation for lot number arsl009a; expiration date (2023-01) was reviewed.The investigation showed that the product met specifications.No associated non-conformances were noted.Based on the lot number batch record review & lot number frequency analysis for lot number arsl009a no capa was required.Sanofi global pharmacovigilance and epidemiology continuously monitored adverse event reports with or without lot numbers, and assessed possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals.This review had not indicated any safety issue.As of 07-may-2021 there were 2 complaint on file for lot number arsl009a and all related sublots.1 complaint was on file for lot number: arsl009: (1) broken syringe while in use.1 complaint on file on lot number arsl009a: (2) adverse event reports.Final investigation complete date was 10-may-2021.Sanofi would continue to monitor complaints as stated in sop (b)(4) "product event handling" to determine if a capa was required.Additional information was received on 23-apr-2021 from the other healthcare professional.Ptc results received and processed.Global ptc number was added.Additional information was received on 28-apr-2021 from patient's son.Event of reaction was due to an interaction between some of the drugs which she usually takes and the vaccine against covid-19 was added with details.Medical history, concomitant medications and batch number for the suspect synvisc one was added.Clinical course updated.Text amended accordingly.Based on information previously received, the following information have been amended: section 4.1 (c) (what further information do you intend in view of reaching final conclusion) of mir was updated.Upon internal review on 07-may-2021, based on information previously received, drug interaction was marked as yes for synvisc one and covid-19 vaccine.Additional information was received on 10-may-2021 from the other healthcare professional.Global ptc results were updated.Text amended accordingly.

Event Description

Reaction was due to an interaction between some of the drugs which she usually takes and the vaccine against covid-19 [drug interaction potentiation], red dots on the head on the neck, face and chest, spread to her back, abdomen and lower limbs [red blotches], vaccine will have potentiated an allergic reaction to another medication [allergic reaction].Case narrative: initial information was received from (b)(6) on 14-apr-2021 regarding an unsolicited valid serious case received from a non-healthcare professional.This case involves (b)(6) year old female patient who had reaction which was due to an interaction between some of the drugs which she usually takes and the vaccine against covid-19 while being treated with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one) and covid-19 vaccine.The patient's past medical treatment(s), vaccination(s) and family history were not provided.Patient was diagnosed with heart failure in (b)(6) 2020 and due to the same, patient regularly takes anticoagulants rivaroxaban (xarelto) and diuretics, which she was unable to specify which ones.Patient had no history of allergies, either to food or medication.On (b)(6) 2021, synvisc one was purchased.On (b)(6) 2021, the patient received treatment with synvisc one once in knee (dose, route, formulation, indication unknown, batch number: arsl009a, expiration date: jan-2023) and it was guaranteed that the product was kept at room temperature until the date of the infiltration.On (b)(6) 2021, patient received covid-19 vaccine (comirnaty) from pfizer for covid-19 vaccination.On (b)(6) 2021, one day later, after latency of 9 days, patient started having allergic reactions, such as red dots on the head on the neck, face and chest which after five days spread to her back, abdomen and lower limbs (rash macular).The opinion of the doctors was that the reaction was due to an interaction between some of the drugs which she usually takes and the vaccine against covid-19 (potentiating drug interaction, onset: 2021, latency: unknown).The vaccine will have potentiated an allergic reaction to another medication (hypersensitivity), which they are still not sure what it was, but they are not related to the administration of synvisc one, so doctors have advised to temporarily stop taking it.Patient was hospitalized on (b)(6) 2021 for the reactions and was monitored by the medical team.Event of potentiating drug interaction and its symptoms assessed as serious due to hospitalization.Reporter had a doubt, about the composition of synvisc one that could, perhaps created an allergic reaction.Patient was discharged on (b)(6) 2021.At the moment doctors are looking forward to the second dose of the vaccine, which will be at the end of (b)(6).Action taken: not applicable for synvisc one and no action taken for covid-19 vaccine.It was not reported if the patient received a corrective treatment.At time of reporting, the outcome was recovered for events of potentiating drug interaction, hypersensitivity and unknown for rash macular.A product technical complaint (ptc) was initiated on 14-apr-2021 for synvisc one.Batch number: arsl009a; comet compliant id number: (b)(6).The production and quality control documentation for lot number arsl009a; expiration date (2023-01) was reviewed.The investigation showed that the product met specifications.No associated non-conformances were noted.Based on the lot number batch record review & lot number frequency analysis for lot number arsl009a no capa was required.Sanofi global pharmacovigilance and epidemiology continuously monitored adverse event reports with or without lot numbers, and assessed possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals.This review had not indicated any safety issue.As of 07-may-2021 there were 2 complaint on file for lot number arsl009a and all related sublots.1 complaint was on file for lot number: arsl009: (1) broken syringe while in use.1 complaint on file on lot number arsl009a: (2) adverse event reports.Final investigation complete date was 10-may-2021.Sanofi would continue to monitor complaints as stated in sop (b)(4) "product event handling" to determine if a capa was required.Additional information was received on 23-apr-2021 from the other healthcare professional.Ptc results received and processed.Global ptc number was added.Additional information was received on 28-apr-2021 from patient's son.Event of reaction was due to an interaction between some of the drugs which she usually takes and the vaccine against covid-19 was added with details.Medical history, concomitant medications and batch number for the suspect synvisc one was added.Clinical course updated.Text amended accordingly.Based on information previously received, the following information have been amended: section 4.1 (c) (what further information do you intend in view of reaching final conclusion) of mir was updated.Upon internal review on 07-may-2021, based on information previously received, drug interaction was marked as yes for synvisc one and covid-19 vaccine.Additional information was received on 10-may-2021 from the other healthcare professional.Global ptc results were updated.Text amended accordingly.

• Brand Name: SYNVISC ONE
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• Manufacturer (Section G): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• Manufacturer Contact: heather schiappacasse ; 55 corporate drive, ms 55b-220; a; bridgewater 08807
• MDR Report Key: 11714668
• MDR Text Key: 262899393
• Report Number: 2246315-2021-00094
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 01/01/2023
• Device Lot Number: ARSL009A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/23/2021
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 04/28/2021; 05/07/2021; 05/10/2021; 05/11/2021; 05/13/2021; 05/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 94 YR