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U.S. Department of Health and Human Services

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

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GENZYME BIOSURGERY (RIDGEFIELD) SYNVISC ONE MOZ Back to Search Results
Lot Number 7RSL021
Device Problems Microbial Contamination of Device (2303); Device Contamination With Biological Material (2908); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Arthritis (1723); Erythema (1840); Fever (1858); Arthralgia (2355); Joint Swelling (2356); Joint Disorder (2373)
Event Date 12/01/2017
Event Type  Injury  
Event Description
This unsolicited case from united states was received on 13-dec-2017 (additional information received on 15- dec-2017, both the information was processed together with clock start date of 13-dec-2017) from a patient's son. This case involves an (b)(6) year old female patient who received treatment with synvisc one and the same day experienced pain, which increased in severity during the night, redness, reaction was not minor and that the area swelled to the size of volley ball/swelling ( 3 x normal size)/knee is tripled the size, knee is inflamed, having knee opened up and drained and scraped out/had to have emergency surgery; after unknown latency was sick with a 104 fever. The patient was having knee pain before treatment. The patient's knee had been broken before. No past drugs, concomitant medication or concurrent condition was reported. On (b)(6) 2017, the patient received treatment with intra-articular synvisc one injection at a dose of 48 ml once (batch/ lot number and expiration date: not provided) into an unspecified location for pretty severe osteoarthritis. The same day, at 1900 hours, the patient was beginning to experience pain, which increased in severity during the night. The patient experienced swelling ( 3 x normal size), swelling and redness. The reaction was not minor and that the area swelled to the size of volley ball. The patient was having pain before treatment, it had increased significantly now. The patient had not had replacement in that knee (reporter could not provide which knee). At the time of reporting on (b)(6) 2017, the patient was having "her knee opened up and drained and scraped out". On an unknown date in (b)(6) 2017, after unknown latency, the patient was sick with a 104 fever (units not provided). The patient had to have emergency surgery. At the time of reporting on (b)(6) 2017, the patient was still in the hospital with broad range antibiotics every 4-6 hours. At some point they had called in the pastor. It was reported that they are aware of a second patient that had the exact same thing. The reported just wanted to not have his mother on "5 bags of broad spectrum antibiotics". Corrective treatment: broad range antibiotics for sick with a 104 fever and knee is inflammed; surgery, knee opened up, drained, scraped and broad range antibiotics for having knee opened up and drained and scraped out/had to have emergency surgery; not reported for rest of the events outcome: unknown for all the events a pharmaceutical technical complaint (ptc) was initiated with global ptc number: (b)(4) 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 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. Sanofi would continue to monitor adverse events to determine if a capa was required. Seriousness criteria: hospitalization and required intervention for all the events additional information was received on 17-jan-2018. Global ptc number and ptc results were added. Clinical course updated. Text was amended accordingly pharmacovigilance comment: sanofi company comment follow up dated 17-jan-2018: follow up information did not change the previous assessment. This case concerns a patient who was hospitalized for experiencing localized erythema and fever after receiving synvisc one injection. Although exact event onset date has not been provided in the case, temporal relationship can still be established between the events and the suspect product based on the available information. However, information regarding injected lot number, injection technique used, past drugs, concomitant medications and other risk factors is required for further case assessment. Additionally, patient's underlying condition of osteoarthritis might be the confounding factor in the occurrence of events.
 
Event Description
This unsolicited case from united states was received on (b)(6) 2017 (additional information received on (b)(6) 2017, both the information was processed together with clock start date of (b)(6) 2017) from a patient's son. This case involves an (b)(6) female patient who received treatment with synvisc one and the same day experienced pain, which increased in severity during the night, redness, reaction was not minor and that the area swelled to the size of volley ball/swelling ( 3 x normal size)/knee is tripled the size, knee is inflamed, having knee opened up and drained and scraped out/had to have emergency surgery; after unknown latency was sick with a 104 fever. The patient was having knee pain before treatment. The patient's knee had been broken before. No past drugs, concomitant medication or concurrent condition was reported. On (b)(6) 2017, the patient received treatment with intra-articular synvisc one injection at a dose of 48 ml once (batch/ lot number and expiration date: not provided) into an unspecified location for pretty severe osteoarthritis. The same day, at 1900 hours, the patient was beginning to experience pain, which increased in severity during the night. The patient experienced swelling ( 3 x normal size), swelling and redness. The reaction was not minor and that the area swelled to the size of volley ball. The patient was having pain before treatment, it had increased significantly now. The patient had not had replacement in that knee (reporter could not provide which knee). At the time of reporting on (b)(6) 2017, the patient was having "her knee opened up and drained and scraped out". On an unknown date in (b)(6) 2017, after unknown latency, the patient was sick with a 104 fever (units not provided). The patient had to have emergency surgery. At the time of reporting on (b)(6) 2017, the patient was still in the hospital with broad range antibiotics every 4-6 hours. At some point they had called in the pastor. It was reported that they are aware of a second patient that had the exact same thing. The reported just wanted to not have his mother on "5 bags of broad spectrum antibiotics". Corrective treatment: broad range antibiotics for sick with a 104 fever and knee is inflamed; surgery, knee opened up, drained, scraped and broad range antibiotics for having knee opened up and drained and scraped out/had to have emergency surgery; not reported for rest of the events outcome: unknown for all the events a pharmaceutical technical complaint (ptc) was initiated and ptc results were pending. Seriousness criteria: hospitalization and required intervention for all the events pharmacovigilance comment: sanofi company comment dated 21-dec-2017: this case concerns a patient who was hospitalized for experiencing localized erythema and fever after receiving synvisc one injection. Although exact event onset date has not been provided in the case, temporal relationship can still be established between the events and the suspect product based on the available information. However, information regarding injected lot number, injection technique used, past drugs, concomitant medications and other risk factors is required for further case assessment. Additionally, patient's underlying condition of osteoarthritis might be the confounding factor in the occurrence of events.
 
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Brand NameSYNVISC ONE
Type of DeviceMOZ
Manufacturer (Section D)
GENZYME BIOSURGERY (RIDGEFIELD)
1125 pleasantview terrace
ridgefield NJ 07657
MDR Report Key7170860
MDR Text Key283481016
Report Number2246315-2017-00427
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
PMA/PMN Number
P940015
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup
Report Date 08/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Lot Number7RSL021
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/21/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 01/07/2018 Patient Sequence Number: 1
Treatment
ACETAMINOPHEN,HYDROCODONE,TABLET; AMLODIPINE (AMLODIPINE),TABLET; APIXABAN (APIXABAN),TABLET; CALCIUM CARBONATE (CALCIUM CARBONATE),; CIPROFLOXACIN HYDROCHLORIDE,TABLET; DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE HYD; DOCUSATE (DOCUSATE),CAPSULE; ELIQUIS (APIXABAN),; ELIQUIS(CON.); FUROSEMIDE (FUROSEMIDE),; LISINOPRIL (LISINOPRIL),; METOPROLOL TARTRATE (METOPROLOL TARTRATE),; OXYCODONE (OXYCODONE),TABLET; PARACETAMOL (PARACETAMOL),; TYLENOL(CON.)
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