MAUDE Adverse Event Report: SANOFI COMPANY / GENZYME CORPORATION SYNVISC INJECTION

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Nausea (1970); Necrosis (1971); Swelling (2091); Ambulation Difficulties (2544)

Event Date 06/10/2018

Event Type  Injury  

Event Description

I recently had 3 synvisc injections from (b)(6) 2018 to (b)(6) 2018 from dr (b)(6) in (b)(6).On (b)(6), my injected knee swelled up and on (b)(6), i was unable to walk.My doctor removed over 120 cc of fluid from my knee and said that would probably be it.My knee began swelling again that night and i drove over an hour each way the next day to have more fluid removed.I went out of town to visit my son for father's day and could only sit on his lazy boy due to my knee swelling.On (b)(6), i went to the er in (b)(6), where the doctor against his better judgement removed over 100 cc of fluid again to relieve me of my pain.I spent the next day on the lazy boy, icing, elevating and taking otc pain meds.Monday, i went to work where i was nauseous for the entire week.Sunday morning; (b)(6), i went to the er at (b)(6).They ct scanned and found infection in my appendix and a foot of my colon had necrosed.They removed a foot of colon and my appendix.I spent two weeks in the hospital and have been recuperating at home the past two weeks.My surgeon went through my colon issue with me and told me i was a mystery in that the issue i had usually appears in the other side of the colon and the reasons that cause this condition normally i tested negative for.I told her of my bad experience with the injections, my following symptoms and she said it's a possibility this spread to my colon to cause this.As there is no other physical explanation, the coincidence and timing cannot be overlooked.I had no idea of your recent recall from december 2017 or any other possible side effects as my doctor simply shot a gel in my knee and sent me packing."are you aware of any tainted batches out now and do you have any product liability claim forms available to complete." (b)(6), date the person first started taking or using the product: (b)(6) 2018; date the person stopped taking or using the product: (b)(6) 2018; 3 injection(s), once a week, injection in right knee.Why was the person using the product: bone to bone/arthritis in right knee.Bone to bone / arthritis in right knee.

• Brand Name: SYNVISC INJECTION
• Type of Device: SYNVISC INJECTION
• Manufacturer (Section D): SANOFI COMPANY / GENZYME CORPORATION
• MDR Report Key: 7717779
• MDR Text Key: 115111987
• Report Number: MW5078568
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 61 YR
• Patient Weight: 110