MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-12-28 for SUTURE UNKNOWN manufactured by Ethicon Inc..
[131633825]
(b)(4). Attempts have been made to retrieve the device. 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. Additional information was reported: after several weeks my suture lines were reddened, swollen with serous and bloody drainage and scabs would form. This situation lasted for weeks. The surgeon explained to me that this was normal healing when using this type of suture. It was not until my 13th week post op that the drainage and scabbing started to decrease. Last week i started to develop scabbing and some additional sutures came to the surface. The suture lines remain a reddened/purple in color and the incision lines are approximately 1/4? Wide... It has significantly caused me concern. I have no doubt a scare revision will need to be done in the future to correct the damage done by using this type of suture. Attempts are being made to obtain the following information. To date no response has been provided. If further details are received at a later date a supplemental medwatch will be sent. Can you clarify what suture product was used during your procedure? How are you currently feeling? If in your possession, may we have a copy of your operative report to review which layer of tissue the suture was used? Does ethicon have your permission to contact your surgeon, in the event ethicon would like to contact your surgeon for more clinical information to be used for a product quality complaint investigation? If so, please provide your surgeon? S name, contact email information and sign release of medical information form
Patient Sequence No: 1, Text Type: N, H10
[131633826]
It was reported by the patient that she underwent a face lift procedure on (b)(6) 2018 and unknown absorbable suture was used. The patient experienced inflammatory reaction with drainage and scabs several weeks post procedure. The patient was evaluated by a dermatologist who opined that sutures can cause inflammation. The patient experienced suture extrusion and redness which has not reduced. It was reported that the suture lines remain a reddened/purple in color and the incision lines are approximately 1/4? Wide. The patient is being evaluated by dermatologist. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2018-78067 |
| MDR Report Key | 8203379 |
| Report Source | CONSUMER |
| Date Received | 2018-12-28 |
| Date of Report | 2018-12-06 |
| Date of Event | 2018-08-23 |
| Date Mfgr Received | 2018-12-31 |
| Date Added to Maude | 2018-12-28 |
| 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 | 2018-12-28 |
| Catalog Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2018-12-28 |