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

Lot Number J1

Device Problem No Apparent Adverse Event (3189)

Patient Problems Pain (1994); Arthralgia (2355); Joint Swelling (2356)

Event Date 09/22/2016

Event Type  Injury  

Manufacturer Narrative

Suspect medical device, genvisc 850 sodium hyaluronate (ha) 10 mg/ml with a (b)(4), was manufactured, tested and released by tedec-meiji farma according to fda approved processes and specifications.(b)(4)., 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 Description

Provider clinic reported to (b)(4) that the pt.Pain level increased in the left knee on (b)(6)2016.Ae assessor spoke with the clinic for further investigation of this report.Pt.Had bilateral knee injections of genvisc 850 for oa diagnosis on (b)(6) 2016.Pt.Continued with weekly injections on alternating knees and received a total of 2 injections in the right knee and 2 injections in the left knee prior to reported increased pain in left knee.On (b)(6) 2016 ultrasound indicates fluid in the suprapatellar space - an effusion with 22 cc of serous fluid removed from the left knee and a cortisone injection was given in the left knee.No pt.Pain rating was provided by the clinic.Clinic did not note or have any diagnostic report indicating infection.Third genvisc injection in left knee was (b)(6) 2016; third genvisc injection in the right knee was (b)(6) 2016.On the (b)(6) 2016 visit the pt.Presented to the clinic with increased pain and swelling in left knee.Pain level was not recorded for the left knee.Clinic states pt.Had an effusion with 21 cc of clear yellow fluid removed by aspiration from the left knee; pt.Was given a cortisone injection in left knee.Clinic did not note or have any diagnostic report indicating infection.Clinic indicated the effusion resolved without issue or sequelae on the (b)(6) 2016 visit and pt.Received 4th genvisc 850 injection on (b)(6) 2016 in left knee and 5th injection on (b)(6) 2016 in left knee; pt.Received three genvisc 850 injections in right knee and five genvisc injections in the left knee.Call center noted pt.Had reactive synovitis, however the clinic notes reviewed with clinic on (b)(6) 2016 did not provide reactive synovitis diagnosis; diagnosis provided to the ae assessor was left knee effusion.This case will be closed without further follow-up from the ae assessor; no remedial action required.This case will be closed as serious due to the report of effusion, however it resolved.

• 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 ; 18870980
• MDR Report Key: 6231836
• MDR Text Key: 64134983
• Report Number: 3003184440-2017-00002
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 00850653006016
• UDI-Public: (01)00850653006016(17)180630(10)J1
• 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: distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/07/2017,10/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Lot Number: J1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/07/2017
• Distributor Facility Aware Date: 10/13/2016
• Device Age: 1 HR
• Event Location: Home
• Date Report to Manufacturer: 10/13/2016
• Date Manufacturer Received: 10/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2015
• 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
• Patient Age: 68 YR