MAUDE Adverse Event Report: GENZYME CORPORATION SYNVISC; ACID, HYALURONIC, INTRAARTICULAR

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

Patient Problems Fatigue (1849); Hair Loss (1877); Hypersensitivity/Allergic reaction (1907); Muscle Weakness (1967); Pain (1994); Rash (2033); Sleep Dysfunction (2517); Ambulation Difficulties (2544); Constipation (3274)

Event Date 11/19/2001

Event Type  Injury  

Event Description

In 2000, i received synvisc injections in both knees.I went to my doctor to get another synvisc injection in (b)(6) 2001.He refused to give me an injection then stating that "synvisc is not a preventative medicine.Come back to get the injection when your knees are inflamed." on (b)(6), i went to my orthopedist, dr.(b)(6), to get a synvisc injection as both of my knees were very swollen and inflamed.Dr.(b)(6) injected me bilaterally.The first symptoms i had, i initially didn't associate with the synvisc shots.The next day, my hair fell out in the back and on the side and a rash appeared on my back.On (b)(6), i returned for my second bilateral injection of synvics.When i arrived home, i was tired and sore and i laid down.When i awoke, i could not stand up.When i finally managed to get up, my walking was greatly impaired.My ability to stand up is still impaired.I was able to walk with the assistance of a crutch on thursday of that week.I wasn't able to sleep because i had horrible muscle pain that keeps me awake all night.I saw dr.(b)(6) on the following monday.He informed me that i had an allergic reaction to the synvisc.He asked me was i allergic to eggs and i told him no.He told me that he didn't think the rash was associated with the synvisc.I made an appointment with a dermatologist who prescribed a steroidal cream.After using two tubes of the cream, i still had the rash.Most disturbing, my ability to walk was greatly impaired.Also, my thigh muscles were so weak, it was difficult for me to walk up stairs -i have 27 steps from my front door to my bedroom.The sunday before seeing dr.(b)(6), i'd gone to my gym and gotten into the therapeutic pool and used the weights.I received some relief.I ask dr.(b)(6) to prescribe physical therapy for me that has been of some relief.I've also noticed that i have horrible constipation.I can only have a bowel movement if i use a laxative.Prior to this, i was regular, daily with my bowel movements.Dr.(b)(6) told me that this would subside in about three weeks.It's been almost two months and i'm still having difficulty walking.I'm afraid i'll never regain my ability to walk.The pain is excruciating and i'm suffering sleep deprivation since i can't sleep at night.My quality of life has suffered greatly as i can't go anywhere that requires walking any distance.I've taken off from work and my holidays were miserable because of this.I want to know if there is any antidote or prescribed treatment for this.I've seen dr.(b)(6) twice since the incident and he just states that it will wear off but, i'm beginning to doubt this.I'm black.I have no egg allergies.I have high blood pressure.I have been in physical therapy since about (b)(6) 2001.

• Brand Name: SYNVISC
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): GENZYME CORPORATION
• MDR Report Key: 10816334
• MDR Text Key: 216104177
• Report Number: MW5097747
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): Y
• 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: 01/14/2002

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 52 YR
• Patient Weight: 90