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

Lot Number K-1

Device Problem No Apparent Adverse Event (3189)

Patient Problems Pain (1994); Arthralgia (2355)

Event Date 06/23/2017

Event Type  Injury  

Event 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
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): TEDEC-MEIJI FARMA; ctra. m-300, km 30, 500; alcala de henares (madrid), 28802 ; SP 28802
• Manufacturer (Section G): TEDEC-MEIJI FARMA; ctra. m-300, km 30,500; alcala de henares, madrid 28802 ; SP 28802
• Manufacturer Contact: celia vazquez lopez ; ctra. m-300, km 30, 500; alcala de henares, madrid 28802 ; SP 28802
• MDR Report Key: 6742620
• MDR Text Key: 80988218
• Report Number: 3003184440-2017-00012
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 00850653006016
• UDI-Public: (01)00850653006016(17)190131(10)K1
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 06/23/2017
• Initial Date FDA Received: 07/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention