MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-11-07 for SUTURE UNKNOWN manufactured by Ethicon Inc..
[91233580]
(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. Attempts are being made to obtain the following information. Product code and lot number of suture involved? What in the physicians opinion are the factors contributing to the patient symptoms of swelling and pain? Please explain what is meant by? Bulge on the left side of the nose? Please explain location of scar tissue. Do you have any photos? Patient pre-operative diagnosis and indication for initial surgery. Procedure name. Initial procedure date. How was the suture placed (interrupted or continuous)? Which tissue layer, at which location, was the suture was used to close? Can you describe the tissue condition when the suture was placed? How was the suture tied? Dates and timelines that patients symptoms first began following the initial surgery and what were the symptoms?
Patient Sequence No: 1, Text Type: N, H10
[91233581]
It was reported that the patient underwent a nose reconstruction procedure on an unknown date and suture was used. Ten months following the procedure, the patient experienced swelling, pain, scar tissue and a bulge on the left side of his nose. The condition was treated with a steroid injection. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2017-70822 |
| MDR Report Key | 7006330 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-11-07 |
| Date of Report | 2017-10-13 |
| Date of Event | 2017-10-01 |
| Date Mfgr Received | 2017-10-13 |
| Date Added to Maude | 2017-11-07 |
| 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 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, NONABSORBABLE |
| Product Code | GAO |
| Date Received | 2017-11-07 |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON INC. |
| Manufacturer Address | P.O. BOX 151, ROUTE 22 WEST SOMERVILLE 088760151 US 088760151 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-11-07 |