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

Model Number	50653-0006-01
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	10/19/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Suspect medical device, genvisc 850 sodium hyaluronate (ha) 10 mg/ml (b)(4), was manufactured, tested and released by tedec-meiji farma according to fda approved processes and specifications.Orthogenrx, inc., as part of the release of the product to the us market and additionally when evaluating this case, reviewed product components-release documentation (e.G.Bulk ha and syringe primary package, among others) as well as manufacturing batch records, product testing, and release documentation.In addition, as part the device design shipping study protocol, upon product arrival to the warehouse, in (b)(4), genvisc 850 was retested for ha content and for sterility.Through out these series of evaluations, genvisc 850 complied with all the requirements of sterility, ha content as well as all the other specification required for release of the product to the us market.No findings were observed that would indicate that there is and issue with the suspect medical device in relation to product manufacturing process and release compliance.
Event or Problem Description
Provider clinic reported to orthogenrx that the pt.Had severe inflammatory reaction to a genvisc 850 injection.Ae assessor has made multiple attempts to reach provider to allow for further investigation of this report.Investigation is limited due to inability to speak with the provider.The case will be closed as serious given the report of a severe inflammatory reaction after the genvisc 850 injection.This case will be closed without further follow-up from ae assessor.If the provider contacts the ae assessor back, the case will be reopened for further investigation.

• 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: 6252880
• Report Number: 3003184440-2017-00004
• Device Sequence Number: 426840
• Product Code: MOZ
• UDI-Device Identifier: 00850653006016
• UDI-Public: (01)00850653006016(17)180630(10)J1
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P140005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date (Section B): 10/19/2016
• Report Date (Section F): 01/15/2017

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: No Information
• Device Expiration Date: 06/30/2018
• Device Model Number: 50653-0006-01
• Device Lot Number: J1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/19/2016
• Date Report to Manufacturer: 10/19/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2016
• Initial Report FDA Received Date: 01/15/2017
• 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
• Date Report Sent to FDA: 01/15/2017