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

Lot Number L-1

Device Problem No Apparent Adverse Event (3189)

Patient Problems High Blood Pressure/ Hypertension (1908); Dizziness (2194)

Event Date 05/08/2017

Event Type  Injury  

Manufacturer Narrative

Suspect medical device, genvisc 850 sodium hyaluronate (ha) 10 mg/ml with a udi (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.Throughout these series of evaluations, genvisc 850 complied with all the requirements, in particular, the ha impurity profile (e.G.Nucleic acids and proteins), product sterility, and ha product 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 an issue with the suspect medical device in relation to product impurities, manufacturing process, and release compliance.

Event Description

Patient reported to (b)(4) call center she was diagnosed with an allergic reaction after her first injection of genvisc 850.The pts.Medical history includes 4 series of 5 injections of hyaluronic acid over the last 5 years for osteoarthritis without any reported side effects.Pt's past medical history is positive for pre-existing hypertension, hypertension crisis, and kidney disease.Pt denies previous known allergies.The pt takes hydralazine, spironolactone, clonidine, valsartan, metoprolol and rosuvastatin.On (b)(6)2017 the pt received her first injections of genvisc850 in both knees; the pt did not check her b/p and it was not checked at the clinic.As she was walking out to her car after the genvisc 850 injections the pt began to feel ill, dizzy and not quite right.When she arrived home she could not stand up without assistance and experienced vertigo.Pt's b/p usually is 115-120 systolically and 60-70 diastolically when her b/p is checked 2-3x/week.Her b/p was checked by a family member at close to 200 systolically.Her health care provider was notified and he had her go to the emergency room(er) at (b)(6).The pt denied redness, swelling, and pain at either of the injection sites.The pt denied hives and respiratory distress.At the er her b/p was checked at 220/110 and she was treated with iv b/p medication.Pt was not sure which b/p medication but did indicate she was given lasix instead of her usual diuretic and also taken off valsartan while in the hospital.The pt was admitted for 23 hours for hospital observation with constant cardiac and b/p monitoring.The pt had blood work, chest x-ray, ct scan, mri, kidney and b/p workup with all results fine.The pt's b/p normalized during that time and was released to home on her regular medications.The vertigo subsided over the next week.The pt reported the b/p was within normal limits at home.The pt was told at the hospital by her three physicians, an intensivist-pulmonologist, neurologist and nephrologist that the hypertension and vertigo were an allergic reaction to genvisc 850.Pt was instructed to avoid any further genvisc 850 injections.The pt recovered without sequelae.This case will be closed as serious without further follow-up from 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: 6800943
• MDR Text Key: 82980006
• Report Number: 3003184440-2017-00013
• Device Sequence Number: 1
• Product Code: MOZ
• 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: 08/17/2017,07/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Lot Number: L-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/17/2017
• Distributor Facility Aware Date: 07/20/2017
• Device Age: 5 MO
• Event Location: Other
• Date Report to Manufacturer: 07/20/2017
• Date Manufacturer Received: 07/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2017
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 61