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| Model Number 50653-0006-01 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Cellulitis (1768); Edema (1820); Pain (1994); Hot Flashes/Flushes (2153); Chills (2191)
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| Event Date 01/11/2019 |
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Event Type
Injury
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Manufacturer Narrative
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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.
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Event Description
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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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Event Description
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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 (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.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 (b)(6) 2019.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.
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Manufacturer Narrative
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The sterility testing done on retention samples available at (b)(6) confirmed genvisc 850 sodium hyaluronate 25 mg.Batch m-3 dates (b)(6) 2019 - (b)(6) 2019 was sterile.The sterile results were documented and witnessed on (b)(6) 2019 by the qc director and qa director.
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