MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2018-08-28 for SUTURE UNKNOWN manufactured by Ethicon Inc..
[118455757]
(b)(4). To date the device has not been returned. If the device or further details are received at a later date a supplemental medwatch will be sent.
Patient Sequence No: 1, Text Type: N, H10
[118455758]
It was reported by the patient that she underwent foot surgery on (b)(6) 2017 and suture was used. The procedure was left foot to remove a broken? Extra? Bone that sat in the tendon on the outside below my ankle. Post operatively, the patient was in walking boot and non-weight bearing. During routine post-operative visit, the outer stitches were removed on an unknown date and patient was allowed to shower. Two weeks later, the surgeon removed the bandage and patient experienced redness, swelling and wound dehiscence. The patient was treated with wound gel, new bandage and follow up with podiatrist weekly with no reported improvement. The treatment changed from wound gel to a collagen powder daily. The patient experienced increased pain and inability to walk without pain. In (b)(6) 2017, the patient was evaluated by wound specialist and sutures were removed on unknown date and tendon exposure was noted. A surgical procedure was performed to debride the wound. The patient had two graft attempts and continued with wound care specialist until (b)(6) 2018 when the wound closed. The patient had physical therapy and continues to experience pain and walking difficulty.
Patient Sequence No: 1, Text Type: D, B5
[122209680]
(b)(4). (b)(4). Additional information was obtained from consumer: ethicon sutures that did not dissolve in the course of my foot surgery, (b)(6)2017, in (b)(6). Op note page 2 notes vicryl was used on tendon and fascia and prolene suture was used for skin closure. I am still having a great deal of pain in my foot and believe there are still un-dissolved "dissolvable" sutures inside my foot. I will see a specialized orthopedic surgeon in hopes of identifying the cause of the pain. Operative note procedure date 11/9/2017 summary: repair of peroneus longus tendon with amniox graft with removal of the os peroneum. Diagnosis: peroneus longus tendinitis with os peroneum syndrome, left anesthesia: popliteal block with local block of marcaine plain with lidocaine with epinephrine procedure notes peroneus longus tendon was identified and three synovitis were removed. The os peroneum was removed. The deep layers of the peroneal longus tendon were repaired with vicryl suture. Fiber wire was used to tubularize the tendon. The amniox graft was placed over the tendon and sutured in place (unknown type). There is a mild bulk factor noted due to the graft but it was able to be reinserted into the lesser retinaculum. The fascial layers were reapproximated with vicryl. The clarix flo was injected into the plantar aspect of the foot along the tendon sheath. The skin was reapproximated with prolene. The foot was dressed with xeroform, 4 x 4? S, kerlix and ace. The patient was placed into a cam walker. The patient tolerated the procedure well. The patient was instructed to be non weight bearing in cam walker as prescribed. If further details are received at the later date a supplemental medwatch will be sent.
Patient Sequence No: 1, Text Type: N, H10
[126154268]
Pc-(b)(4). Additional information was requested and the following medical record summary was obtained: the patient underwent a repair of peroneus longus tendon (incision on the lateral aspect of left foot) with amniox graft on (b)(4) 2017. Vicryl sutures were used for subcuticular tissue approximation. Culture revealed enterococcus, a common bacteria for wound infection was found. The patient had a delayed foot wound healing which was first identified in the records on (b)(4) 2018. On (b)(4) 2018 it was noted that there was a? Scant growth of enterococcus? Which was treated with anasept and gentamicin applied topically. The records also indicate the patient had been using collagen therapy at home following the initial procedure and topical collagen was used to stimulate new granulation tissue with a foam dressing applied. The wound eventually healed by (b)(4) 2018. The alleged suture was coated vicryl suture, which was used in subcuticular tissue closure and an absorbable suture with essential dissolving time within 70 days after implementation; however, the absorption time may be longer where there is limited blood circulation or the hydrolosis process takes longer. Prolene sutures were used for skin closure, which are non absorbable suture and need to be removed following surgery.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2210968-2018-75473 |
| MDR Report Key | 7823463 |
| Report Source | OTHER |
| Date Received | 2018-08-28 |
| Date of Report | 2018-09-05 |
| Date of Event | 2017-11-09 |
| Date Mfgr Received | 2019-01-14 |
| Date Added to Maude | 2018-08-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DARLENE KYLE |
| Manufacturer Street | P.O. BOX 151, ROUTE 22 WEST |
| Manufacturer City | SOMERVILLE NJ 088760151 |
| Manufacturer Country | US |
| Manufacturer Postal | 088760151 |
| Manufacturer Phone | 9082182792 |
| Manufacturer G1 | ETHICON INC. |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUTURE UNKNOWN |
| Generic Name | SUTURE, ABSORBABLE, SYNTHETIC |
| Product Code | GAK |
| Date Received | 2018-08-28 |
| Catalog Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON INC. |
| Manufacturer Address | P.O. BOX 151, ROUTE 22 WEST SOMERVILLE NJ 088760151 US 088760151 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-08-28 |