MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2014-07-02 for RETENTION SUTURE BRIDGE UNK RSB5 manufactured by Ethicon Inc..
[4514333]
It was reported that a patient underwent a surgical procedure on an unknown date and a suture retention bridge was used. The patient experienced a skin necrosis on the same day and the incision wasn't properly closed. The incision reopened with the bridge in place. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
[12031376]
(b)(4). 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 | 2210968-2014-08603 |
| MDR Report Key | 3909435 |
| Report Source | 01,05,06,07 |
| Date Received | 2014-07-02 |
| Date of Report | 2014-06-11 |
| Date of Event | 2014-03-12 |
| Date Mfgr Received | 2014-06-10 |
| Date Added to Maude | 2014-07-02 |
| 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 | 0 |
| Event Location | 0 |
| 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 | UNKNOWN |
| Manufacturer Street | UNKNOWN |
| Manufacturer City | X |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RETENTION SUTURE BRIDGE |
| Generic Name | SUTURE ACCESSORIES |
| Product Code | KGS |
| Date Received | 2014-07-02 |
| Model Number | UNK |
| Catalog Number | RSB5 |
| Lot Number | UNK |
| 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 08876015 US 08876 0151 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-07-02 |