MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-05-08 for MERS TAPE WHT 30CMX5MM S/A MO-4 RS23 manufactured by Ethicon Inc..
[144835602]
(b)(4). Attempts are being 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.
Patient Sequence No: 1, Text Type: N, H10
[144835604]
It was reported that the patient underwent gynecological procedure on (b)(6) 2019 and suture was used. During the cervical cerclage, the needle broke in half passing through the cervix. Both pieces were retrieved without further incident. The procedure was completed with another device of the same product code. There were no patient consequences reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2019-81183 |
| MDR Report Key | 8591861 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-05-08 |
| Date of Report | 2019-04-11 |
| Date of Event | 2019-03-15 |
| Date Mfgr Received | 2019-05-27 |
| Date Added to Maude | 2019-05-08 |
| 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 | MERS TAPE WHT 30CMX5MM S/A MO-4 |
| Generic Name | CLASS I DEVICE - EXEMPT |
| Product Code | KDC |
| Date Received | 2019-05-08 |
| Returned To Mfg | 2019-05-24 |
| Catalog Number | RS23 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-05-08 |