MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-05 for ETHILOOP SILICON SLING UNK EH7700E manufactured by Ethicon Inc..
[44908703]
(b)(4). To date, the device has not been returned. If the product is returned for evaluation, any further info derived from the evaluation will be submitted in a supplemental 3500a form. This product is not approved in the us or used in the us. It is similar to us suture.
Patient Sequence No: 1, Text Type: N, H10
[44908704]
It was reported that the patient underwent an unknown procedure on unknown date and suture was used. During the procedure, the needle pulled off. There were no patient consequences reported. Another like device was used to complete the procedure. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
[46691224]
The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot. The actual device was returned for evaluation. The complaint sample returned showed a separating of the needle and suture. The loose separated needle was visually examined and found to have correct swage. The suture remnant was well-positioned inside the barrel without damages. The separated suture was visually examined and found to have no defects or damages. The cause of separating could not be determined. No conclusion can be drawn at this time. Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2210968-2016-08739 |
| MDR Report Key | 5633877 |
| Date Received | 2016-05-05 |
| Date of Report | 2016-04-13 |
| Date Mfgr Received | 2016-06-06 |
| Device Manufacturer Date | 2015-05-20 |
| Date Added to Maude | 2016-05-05 |
| 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 | GUILLERMO VILLA |
| Manufacturer Street | ROUTE 22 WEST PO BOX 151 |
| Manufacturer City | SOMERVILLE NJ 08876 |
| Manufacturer Country | US |
| Manufacturer Postal | 08876 |
| Manufacturer Phone | 9082180707 |
| Manufacturer G1 | ETHICON INC.-JUAREZ |
| Manufacturer Street | AVENIDA DE LAS TORRES 7125, CO L SALVACAR |
| Manufacturer City | CIUDAD JUAREZ 32604 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 32604 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ETHILOOP SILICON SLING |
| Generic Name | CLASS I DEVICE - EXEMPT |
| Product Code | GCZ |
| Date Received | 2016-05-05 |
| Returned To Mfg | 2016-06-06 |
| Model Number | UNK |
| Catalog Number | EH7700E |
| Lot Number | JE6991 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2016-05-05 |