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Model Number 50653-0006-01
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cellulitis (1768); Edema (1820); Pain (1994); Hot Flashes/Flushes (2153); Chills (2191)
Event Date 01/11/2019
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. Orthogenrx, inc. , as part of the release of the product to the us market and additionally when evaluating this case ((b)(4)), 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, components and final product sterility, 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 manufacturing process, sterility and release compliance with product specifications. Sterility testing on a retained sample from lot m-3 is in process to confirm sterility compliance.
Event Description
Patient (pt. ) phoned the call center for orthogenrx genvisc 850 on (b)(6) 2019 with a complaint of signs/symptoms of pain, itching, swelling in his calves, feet and ankles, blisters around his ankles and redness in his legs bilaterally beginning on (b)(6) 2019 and continuing; pain is 6-7, on a scale of 0 is no pain and 10 is the worst possible pain. Pt. Denies drainage from his legs. Pt. Denies his legs are hot to the touch. Pt. Was not able to describe the extent of the swelling except to say he has not been able to lace up his boots due to the swelling. Pt. Began having chills intermittently with hot flashes on (b)(6) 2019. Pt. Has a past medical history of bilateral osteoarthritis, pain in legs bilaterally of a level 10, chronic instability of the knee, diabetes, bmi >30 indicating obesity, and his vascular specialist has recommended 'two stents for blood flow problems in his lower extremities and leg wraps'. Pt. Received genvisc 850 knee injections bilaterally on (b)(6) 2019 for pain due to osteoarthritis and a second injection bilaterally approximately a week later. Pt. Reported decreased osteoarthritic pain after genvisc 850 injections. The clinic visit for the third genvisc 850 knee injection was held on (b)(6) 2019, but the dose was not given because the health care provider (hcp) noticed the redness in his calves, swelling in his calves feet and ankles bilaterally. The ae assessor spoke with the hcp clinic for further investigation. Hcp provider shared that the pt. Saw his vascular specialist prior to the third scheduled genvisc 850 knee injection approximately (b)(6) 2019 and was prescribed keflex for cellulitis. The hcp encouraged the pt. To begin taking the keflex. The ae assessor spoke with the pt. For follow-up on (b)(6) 2019. The pt. Reported greatly improved signs/symptoms; the previous bilateral extremity redness is primarily pink, pain level is improved, and the swelling has gone down in his calves. There is still some remaining swelling in his ankles and feet. He is almost finished taking the keflex. It is likely the pt. Had a bacterial infection. The source of the bacteria is unknown. The genvisc 850 batch record confirms no finding of any contamination prior to release for use. The procedure for the genvisc850 injection the health care provider explained is to: use fluoroscopy, inject lidocaine from a multiuse vial into the knee, remove the syringe from the needle and attach the genvisc 850 product device and inject. Obesity and circulatory problems may be contributory factors to the infectious process. According to pt. , the vascular center informed him he had the potential for bilateral lower extremity ulcer development. There is inadequate information from the hcp regarding pts. Skin condition pre-genvisc 850. With the limited information in this case the cause of the cellulitis cannot be determined at this time. The genvisc 850 injections cannot be ruled out due to the temporal sequence of the adverse event. The likely contributing factors to the complaint/case signs and symptoms are due to a bacterial infection, obesity and circulatory problems.
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Brand NameGENVISC 850
Manufacturer (Section D)
ctra. m-300, km 30, 500-28802
alcala de henares (madrid),
Manufacturer (Section G)
ctra. m-300, km 30,500-28802
alcala de henares, madrid
Manufacturer Contact
celia vazquez lopez
ctra. m-300, km 30, 500-28802
MDR Report Key8364992
MDR Text Key136988620
Report Number3003184440-2019-00001
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/22/2019,01/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/24/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/30/2021
Device Model Number50653-0006-01
Device Lot NumberM-3
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/22/2019
Distributor Facility Aware Date01/25/2019
Device Age7 MO
Event Location No Information
Date Report to Manufacturer01/25/2019
Date Manufacturer Received01/25/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/01/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/24/2019 Patient Sequence Number: 1