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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENZYME BIOSURGERY (RIDGEFIELD) SYNVISC ONE INTRA-ARTICULAR HYALURONIC ACID

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GENZYME BIOSURGERY (RIDGEFIELD) SYNVISC ONE INTRA-ARTICULAR HYALURONIC ACID Back to Search Results
Lot Number 7RSL018A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Arthritis (1723); Bacterial Infection (1735); Sepsis (2067)
Event Date 10/27/2017
Event Type  Injury  
Event Description
This unsolicited case from united states was received on 12-dec-2017 from the orthopedic physician on behalf of the patient. This case concerns a (b)(6) year old female patient who received treatment with synvisc one injection and after 3 days the patient experienced bad infection in right knee/ culture tested positive for streptococcus sanguinis. Concurrent condition included diabetes. Prior to the (b)(6) injection, the patient was said to have been injected with synvisc one at least three times without complication. Just prior to the synvisc-one injection, the patient's temp was 99. 1. On (b)(6) 2017, the patient received treatment with intra-articular synvisc one injection, once (lot number: 7rsl018a; dose and expiration date: may-2020) for osteoarthritis in the right knee. On (b)(6) 2017 (three days later), the patient developed a bad infection in the right knee. Patient was hospitalized for four days and then was admitted to a rehab facility. The patient required the knee to be "washed" out three times while in the hospital. During the patient's hospital stay, the wbc reached 14. 7, neutrophil count reached 79 (units unspecified). The patient culture tested positive for streptococcus sanguinis. The patient's highest temperature in the hospital was 100. 3 f (40 degree c). The patient was on her last day of an antibiotic regimen called ceftriaxone. The patient received unspecified intravenous (iv) antibiotics while in the hospital. The patient was now being seen by her primary care physician. Corrective treatment: ceftriaxone, antibiotics, knee to be "washed" out outcome: unknown a pharmaceutical technical complaint (ptc) was initiated with global ptc number: (b)(4) the production and quality control documentation for lot # 7rsl018 expiration date (05/2020) was reviewed. The investigation showed that the product met specifications. No associated non-conformances were noted. Based on the lot # batch record review & lot # frequency analysis for lot # 7rsl018 no capa was required. 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 had not indicated any safety issue. Sanofi would continue to monitor in order to determine if a capa was required. Seriousness criterion: in-patient hospitalization and required intervention additional information was received on 23-jan-2018. Global ptc number and ptc results were added. Clinical course updated. Text was amended accordingly. Pharmacovigilance comment: sanofi company comment dated 23-jan-2018:the additional information does not alter the previous case assessment. This case concerns a female patient who received synvisc one injection and was tested positive for streptococcus sanguinis. Based upon the information available, the causal role of the product cannot be denied for the occurrence of events. However, there is no information regarding technique of injection and whether aseptic conditions were maintained during the injection. Further information regarding patient's current clinical presentation, medical history, concomitant medications and other risk factors would aid in the complete medical assessment of the case.
 
Event Description
This unsolicited case from united states was received on (b)(6) 2017 from the orthopedic physician on behalf of the patient. This case concerns a (b)(6) year old female patient who received treatment with synvisc one injection and after 3 days the patient experienced bad infection in right knee/ culture tested positive for streptococcus sanguinis. Concurrent condition included diabetes. Prior to the (b)(6) injection, the patient was said to have been injected with synvisc one at least three times without complication. Just prior to the synvisc-one injection, the patient's temp was 99. 1. On (b)(6) 2017, the patient received treatment with intra-articular synvisc one injection, once (lot number: 7rsl018a; dose and expiration date: not reported) for osteoarthritis in the right knee. On (b)(6) 2017 (three days later), the patient developed a bad infection in the right knee. Patient was hospitalized for four days and then was admitted to a rehab facility. The patient required the knee to be "washed" out three times while in the hospital. During the patient's hospital stay, the wbc reached 14. 7, neutrophil count reached 79 (units unspecified). The patient culture tested positive for streptococcus sanguinis. The patient's highest temperature in the hospital was 100. 3 f (40 degree c). The patient was on her last day of an antibiotic regimen called ceftriaxone. The patient received unspecified intravenous (iv) antibiotics while in the hospital. The patient was now being seen by her primary care physician. Corrective treatment: ceftriaxone, antibiotics, knee to be "washed" out outcome: unknown. A pharmaceutical technical complaint (ptc) was initiated and results were pending for the same. Seriousness criterion: in-patient hospitalization and required intervention. Pharmacovigilance comment: sanofi company comment dated (b)(6) 2017: this case concerns a female patient who received synvisc one injection and was tested positive for streptococcus sanguinis. Based upon the information available, the causal role of the product cannot be denied for the occurrence of events. However, there is no information regarding technique of injection and whether aseptic conditions were maintained during the injection. Further information regarding patient's current clinical presentation, medical history, concomitant medications and other risk factors would aid in the complete medical assessment of the case.
 
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Brand NameSYNVISC ONE
Type of DeviceINTRA-ARTICULAR HYALURONIC ACID
Manufacturer (Section D)
GENZYME BIOSURGERY (RIDGEFIELD)
1125 pleadantview terrace
ridgefield NJ 07657
MDR Report Key7171742
MDR Text Key284355086
Report Number2246315-2017-00411
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 health professional
Type of Report Initial,Followup,Followup
Report Date 12/12/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/08/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/01/2020
Device Lot Number7RSL018A
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/05/2018
Is This a Reprocessed and Reused Single-Use Device?

Patient Treatment Data
Date Received: 01/08/2018 Patient Sequence Number: 1
Treatment
DILAUDID(CON.); LUMIGAN(CON.)-START; LUMIGAN(CON.)-STOP-UNKNOWN; METFORMIN(CON.)-START; METFORMIN(CON.)-STOP-UNKNOWN; METHOCARBAMOL(CON.)-START; METHOCARBAMOL(CON.)-STOP-UNKNOWN; NITROFURANTOIN(CON.)-START; NITROFURANTOIN(CON.)-STOP-UNKNOWN; SYNVISC ONE(PREV.); SYNVISC ONE(PREV.); SYNVISC ONE(PREV.); TRAMADOL(CON.)-START; TRAMADOL(CON.)-STOP-UNKNOWN; SYNVISC ONE (PREV.)
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