MAUDE Adverse Event Report: TEDEC-MEIJI FARMA GENVISC 850; ACID, HYALURONIC, INTRAARTICULAR

Lot Number	K-1
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Pain (1994); Arthralgia (2355)
Date of Event	06/23/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported to orthogenrx genvisc 850 call center the first 3 injections of genvisc 850 went well.After the 4th injection of genvisc 850 his knee felt worse and he had fluid drained.When he walks the knee hurts.The bone feels broken inside.When bending the knee a sound like "ke ke ke" occurs, likely crepitus.This ae assessor has placed multiple calls to the pt.And the pt.Has not answered nor returned the calls.It is not possible to assess contributory factors without the pts.Medical history, pain level and diagnostics if any were performed.The genvisc 850 cannot be ruled out as a contributing factor.If the pt.Returns the calls, the case will be reopened for further investigation.Based upon the information provided no remedial action is required.This case is being closed as a serious because the pt.Reported an effusion with significant pain after the 4th genvisc850 injection.The case is limited in investigation and will be closed without further follow-up from the ae assessor.

• Brand Name: GENVISC 850
• Common Device Name: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): TEDEC-MEIJI FARMA; ctra. m-300, km 30, 500; alcala de henares (madrid), 28802 ; SP 28802
• MDR Report Key: 6742620
• Report Number: 3003184440-2017-00012
• Device Sequence Number: 590340
• Product Code: MOZ
• UDI-Device Identifier: 00850653006016
• UDI-Public: (01)00850653006016(17)190131(10)K1
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P140005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/23/2017
• Report Date (Section F): 06/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2019
• Device Lot Number: K-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/23/2017
• Date Report to Manufacturer: 06/23/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2017
• Initial Report FDA Received Date: 07/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention