MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2018-12-05 for SUTURE UNKNOWN manufactured by Ethicon Inc..
[129437214]
(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. Summary of attached: patient born (b)(6) with perforated anus and rectourethral fistula. On (b)(6) 2011 underwent diverting sigmoid colostomy. A vaseline gauze was placed over the distal mucous fistula. (notes state patient needed to grow prior to repairing fistula). On (b)(6) 2012 posterior sagittal anorectal plasty with repair of rectourethral fistula. On (b)(6) 2012 resection of distal colon and rectum with colorectal anastomosis for closure of divided colostomy. The anastomosis was performed with 5-0 pds suture. A leak test was performed,? There was no obvious leakage and suture was placed to reinforce any area that appeared to have any bubbles?. On (b)(6) 2012 exploratory laparotomy, washout of the abdomen, creation of diverting colostomy and mucous fistula. ? The previous anastomosis was identified and a couple of stitches in the anterior wall of the anastomosis appeared to have dehisced.? A diverting colostomy was performed. Findings: "the patient had evidence of leak from his anastomosis. The anterior sutures were dehisced leading to intraperitoneal leakage. There were no other anomalies found. "
Patient Sequence No: 1, Text Type: N, H10
[129437215]
It was reported by an attorney that a patient underwent a resection of distal colon and rectum with colorectal anastomosis for closure of divided colostomy on (b)(6) 2012 and suture was used. The anastomosis was performed with unknown suture. A leak test was performed,? There was no obvious leakage and suture was placed to reinforce any area that appeared to have any bubbles?. The patient experienced dehiscence on an unknown date and an emergency corrective procedure was performed. On (b)(6) 2012 exploratory laparotomy, washout of the abdomen, creation of diverting colostomy and mucous fistula. ? The previous anastomosis was identified and a couple of stitches in the anterior wall of the anastomosis appeared to have dehisced.? A diverting colostomy 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 | 2210968-2018-77530 |
| MDR Report Key | 8134032 |
| Report Source | OTHER |
| Date Received | 2018-12-05 |
| Date of Report | 2018-11-20 |
| Date of Event | 2012-11-19 |
| Date Mfgr Received | 2018-11-20 |
| Date Added to Maude | 2018-12-05 |
| 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 | 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 | 2018-12-05 |
| Catalog 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 088760151 US 088760151 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-12-05 |