MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2018-08-21 for SUTURE UNKNOWN manufactured by Ethicon Inc..
[117724382]
(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
[117724383]
It was reported by an attorney that a patient underwent a colon procedure on an unknown date and suture was used. The patient experienced dehiscence on an unknown date and an emergency corrective procedure was performed. The current condition of the patient is unknown. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2018-75298 |
| MDR Report Key | 7800937 |
| Report Source | OTHER |
| Date Received | 2018-08-21 |
| Date of Report | 2018-07-31 |
| Date of Event | 2012-11-01 |
| Date Mfgr Received | 2018-11-20 |
| Date Added to Maude | 2018-08-21 |
| 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 | 2018-08-21 |
| Catalog Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 2018-08-21 |