MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other report with the FDA on 2019-07-30 for SUTURE UNKNOWN manufactured by Ethicon Inc..
[152780490]
(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: the actual device batch number associated with this event is not known. The possible batch number is reported as follows: mpcbssa0. 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. Please provide suture product code mpcbssao. Invalid lot - please provide correct lot.
Patient Sequence No: 1, Text Type: N, H10
[152780491]
It was reported that a patient underwent an unknown gynecological procedure on (b)(6) 2019 and suture was used. The suture broke during use. Another device was used to complete the procedure. There were no adverse patient consequences reported. No additional information could be provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2019-84895 |
| MDR Report Key | 8844251 |
| Report Source | FOREIGN,OTHER |
| Date Received | 2019-07-30 |
| Date of Report | 2019-07-03 |
| Date of Event | 2019-06-11 |
| Date Mfgr Received | 2019-08-27 |
| Date Added to Maude | 2019-07-30 |
| 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. |
| Manufacturer Street | P.O. BOX 1409 D22841 |
| Manufacturer City | NORDERSTEDT |
| 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 | 2019-07-30 |
| 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 | 2019-07-30 |