MAUDE Adverse Event Report: GENZYME CORPORATION SYNVISC HYLAN G-F 20; ACID, HYALURONIC, INTRAARTICULAR

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Diarrhea (1811); Dyspnea (1816); Itching Sensation (1943); Rash (2033); Swelling (2091); Urinary Retention (2119)

Event Date 10/27/2000

Event Type  Injury  

Event Description

Giving injection in left knee of synvisc (b)(6) 2000 and the following day (b)(6) 2000 truncal itching, rash all the way to head.On (b)(6) 2000 lips swollen twice their size and patient was hospitalized.Urinary retention, expulsive diarrhea, swollen face, tachypneic, trouble breathing, sore throat, eyes swollen shut, transferred to our hospital on (b)(6) for continued steroid tx required epinephrine 1:1000; solumedrol; benadryl; inhalation racepinephrine.(b)(4).

• Brand Name: SYNVISC HYLAN G-F 20
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): GENZYME CORPORATION
• MDR Report Key: 10811206
• MDR Text Key: 215618291
• Report Number: MW5097719
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 12/06/2000

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 69 YR