MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature report with the FDA on 2018-11-27 for MERSILENE TAPE UNKNOWN PRODUCT manufactured by Ethicon Inc..
[128468419]
(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. Attempts are being made to obtain the following information. If further details are received at the later date a supplemental medwatch will be sent. Were the cases discussed in this article previously reported to ethicon? If yes, please provide a complaint reference number. Does the surgeon believe that ethicon products involved caused and/or contributed to the post-operative complications described in the article? Does the surgeon believe there was any deficiency with the ethicon products used in this procedure? Citation: journal of orthopaedic surgery and research 2014, 9: 42; doi:10. 1186/1749-799x-9-42. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[128468420]
It was reported via journal article: title: "comparison of single coracoclavicular suture fixation and hook plate for the treatment of acute unstable distal clavicle fractures," authors: chun-yu chen, shan-wei yang, kuan-yu lin, kai-cheng lin, yih-wen tarng, jenn-huei renn and chia-hsin lai, citation: journal of orthopaedic surgery and research 2014, 9: 42; doi:10. 1186/1749-799x-9-42. The purpose of this study was to retrospectively evaluate the clinical results and efficacy comparison of single coracoclavicular (cc) suture fixation with mersilene tape versus clavicular hook plating for the treatment of acute unstable distal clavicle fractures. Between dec2004 and aug2010, 68 patients with neer type iib distal clavicular fractures were surgically treated with either single cc suture fixation with mersilene tape, m group (n=40; n=28 male and n=12 female; mean age of 43. 2 years [ranged 18-75 years]) or clavicular hook plating, h group (n=28; n=16 male and n=12 female; mean age of 48. 3 years [28-78 years]). In m group, a right angle clamp was used to pass the mersilene tape through the inferior base of the "cocacoid" process and around the medial clavicular segment. The mersilene tape was tied for cc stabilization. Postoperative complications in m group included superficial wound infection (n=1) which healed well after the treatment of surgical debridement and administration of antibiotics; and frozen shoulder of the operated side (n=1) which resolved after adequate rehabilitation without any surgical intervention. Both the surgical methods of single cc suture fixation with mersilene tape and ao clavicular hook plate could provide good union rate and functional results for the treatment of unstable distal clavicle fractures. Single cc suture fixation had additional advantages including less blood loss and operative time, avoidance of acromial morbidity, nonnecessity of further surgical removal of the implant, and early recovery of shoulder range of motion.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2018-77352 |
| MDR Report Key | 8107604 |
| Report Source | FOREIGN,LITERATURE |
| Date Received | 2018-11-27 |
| Date of Report | 2018-11-09 |
| Date Mfgr Received | 2018-11-09 |
| Date Added to Maude | 2018-11-27 |
| 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 | MERSILENE TAPE UNKNOWN PRODUCT |
| Generic Name | INSTRUMENT, SURGICAL, DISPOSABLE |
| Product Code | KDC |
| Date Received | 2018-11-27 |
| 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 | 2018-11-27 |