MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature report with the FDA on 2018-10-11 for ETHILOOP SILICON SLING UNKNOWN PRODUCT manufactured by Ethicon Inc..
[123497462]
(b)(4). This report is related to a journal article, therefore no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided. Citation: arch surg/vol 146 (no. 6), june 2011. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[123497463]
It was reported via journal article: "title: dynamic parietal closure: initial experience of an original parietal closure procedure for treatment of abdominal wound dehiscence" authors: quentin qassemyar, md, franc? Ois browet, md, micheline robbe, md, phd, pierre verhaeghe, md, phd and jean-marc regimbeau, md, phd. Citation: arch surg/vol 146 (no. 6), june 2011. The aim of this paper was to discuss the authors? Developed? Dynamic parietal closure? Technique in which silicone loop sutures were used to strengthen a conventional aponeurotic closure. The procedure was simple, quick, inexpensive, and compatible with digestive stomas and complex peritoneal drainage. It has the advantages but not the disadvantages of the use of retention sutures or abdominal wall plastic surgery. From january 2009 to december 2010, the authors performed a prospective study of 873 consecutive patients who underwent a midline laparotomy. During the procedure, at the time of parietal closure, successive mass closures were performed along the entire length of the median laparotomy with elastic silicone loops (45 cm in length and 2mmin diameter [ethiloop; ethicon, (b)(4)]). Each loop was screwed onto the proximal end of a needle (as in drain externalization) and was placed transfascially across the wound to obtain a u-shaped suture every 4 cm. The incisions were closed by a continuous, aponeurotic suture (pds; ethicon, somerville, new jersey). The skin was closed conventionally. Lastly, the dynamic parietal closure? S tension was adjusted, and compresses were placed between the skin and the loops. The overall incidence rate for abdominal wound dehiscence (diagnosed clinically within 2 weeks of the operation) was (n=16). The etiology of abdominal wound dehiscence was mechanical in 12 patients and septic in 4 patients. The abdominal wound dehiscence recurrence rate was 0%. All cases of abdominal wound dehiscence performed an emergency procedure to redo the midline laparotomy, examine the abdominal cavity (to check for infection), and then perform the dynamic parietal closure technique. In conclusion, dynamic parietal closure is an original, easy, inexpensive, and efficient procedure. It must be evaluated with larger numbers of patients. In individuals with a very high risk of abdominal wound dehiscence, the dynamic parietal closure technique could perhaps be performed preventively.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2018-76469 |
| MDR Report Key | 7957145 |
| Report Source | FOREIGN,LITERATURE |
| Date Received | 2018-10-11 |
| Date of Report | 2018-09-21 |
| Date Mfgr Received | 2018-09-21 |
| Date Added to Maude | 2018-10-11 |
| 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 | ETHILOOP SILICON SLING UNKNOWN PRODUCT |
| Generic Name | RETAINER, SURGICAL |
| Product Code | GCZ |
| Date Received | 2018-10-11 |
| Catalog Number | UNK |
| 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 088760151 US 088760151 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-10-11 |