MAUDE Adverse Event Report:

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Swelling (2091); Skin Inflammation (2443)

Event Type  No Answer Provided  

Manufacturer Narrative

The sterility testing done on retention samples available at tedec-meiji farma (b)(4) confirmed genvisc 850 sodium hyaluronate 25 mg.Batch m-3 dates 02/21/2019-03/07/2019 was sterile.The sterile results were documented and witnessed on 03/08/2019 by the qc director and qa director.

Event Description

Ae assessor reviewed the vascular clinic medical records for further follow-up of a patient (pt.) complaint of bacterial cellulitis beginning on (b)(6) 2019 and resolving by (b)(6) 2019.His pain was a level of 6-7, on a scale of 0 is no pain and 10 is the worst possible pain.Pre-genvisc 850 injections pt.Has a medical history of varicose veins in the bilateral lower extremities managed with ablation, sclerotherapy and compression stockings.Pts.Initial vascular clinic examination on (b)(6) 2018 revealed "hemosiderin staining in the gaiter distribution bilaterally right>left and a pre- ulcerative area at the right medial malleolar area." on (b)(6) 2018 the pt.Had the following procedure in the vascular clinic: "right incompetent perforating venous ablation, sclerotherapy injection of left great saphenous vein for right and left lower extremity superficial venous insufficiency with swelling and valvular insufficiency of an incompetent venous perforator demonstrated by duplex ultrasound".On (b)(6) 2018 at the vascular clinic, pts.Lower extremities measured: left calf 37.9 cm; left ankle 23.5 cm; right calf 37.6 cm; right ankle 24.2 cm and pt.Complained of a hard area on right lower leg where vein is closing off from procedure of (b)(6) 2018.On (b)(6) 2018 the pt.Presented to the vascular clinic with complaints of heaviness, knots and skin discoloration of his lower extremities bilaterally.His health care provider (hcp) recommended a right leg venogram.At a pain and rehab clinic (p.R.Clinic) the pt.Received genvisc 850 knee injections bilaterally on (b)(6) 2019 and (b)(6) 2019.Pt.Reported decreased osteoarthritic pain after genvisc 850 injections.The p.R.Clinic visit for the third genvisc 850 knee injection was (b)(6) 2019, but the dose was not given because the hcp noticed the redness in his calves, swelling in his calves feet and ankles bilaterally.On (b)(6) 2019 the pt.Presented to the vascular clinic with a complaint of both legs swelling and hurting.The pts.Lower extremities measured: left calf 42.3 cm; left ankle 28.8 cm; right calf 45.5 cm; right ankle 27 cm.Pt.Reported increased redness in his lower legs bilaterally and had taken cipro he had left over at home and it wasn't helping.Venogram was recommended for possible stenting.Hemosiderin staining and erythema in the gaiter distribution bilaterally right >left.Hyperkeratosis, "thickening of the outer layer of the epidermis', noted bilateral lower legs positive stemmers sign which is a 'thickened fold of skin at the base of the second toe or second finger that can be gently pinched and lifted".It is an early diagnostic test for lymphedema.Pt underwent an ultrasound of the right lower leg extremity which indicated he did not have a dvt.The hcps impression was "cellulitis bilateral lower extremities, lymphedema, venous hypertension bilateral, and suspicion for vein compression due to calf discrepancy." the hcp prescribed 1 gram ceftriaxone intramuscular injection given in the office and keflex 500mg bid for 10 days.Pt.Was being scheduled for lymphedema treatment and right lower extremity venogram with possible stent placement.The ae assessor spoke with the pt.For follow-up on 2/1/19.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.In summary, the pts.Medical records indicated the pt.Had a pre-genvisc850 injection history of bilateral lower extremity vascular issues with hard tissue areas still healing from the venous ablation and sclerotherapy.On (b)(6) 2019 the pt.Presented back to the vascular clinic with increased swelling, hyperkeratosis, positive stemmers sign bilaterally indicating lymphedema.The hcp diagnosed bilateral lower extremities cellulitis (confined to calf and ankles) and prescribed an injection of an antibiotic in the office and keflex 500mg bid for 10 days.The cellulitis resolved by 2/1/19.Np (b)(6) from the p.R.Clinic stated the pts.Signs and symptoms including the swelling are not related to the genvisc 850.She stated there had been no swelling around the knees.The pre-existing vascular issues which have required medical intervention were the likely cause of the cellulitis; obesity (pts.Bmi of 33) may also be a contributing issue to the vascular issues and healing.In conclusion, upon review of the medical records from the vascular clinic there is no indication of the genvisc 850 injections in the knees contributing to the cellulitis in the calves and ankles.

• MDR Report Key: 8793746
• MDR Text Key: 151342247
• Report Number: 3011402886-2019-00001
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Age: 7 MO
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/16/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 104