MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature report with the FDA on 2018-11-20 for MERSILENE TAPE UNKNOWN PRODUCT manufactured by Ethicon Inc..
[127943625]
(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: orthopedics june 2011 - volume 34, issue 6: e172-e177; doi: 10. 3928/01477447-20110427-10. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[127943626]
It was reported via journal article: title: "treatment of acute unstable distal clavicle fractures with single coracoclavicular suture fixation. " authors: shan-wei yang, md; li chun lin, md; shwu jen chang, phd; shwu jen chang, md; shyh ming kuo, phd; lain-chyr hwang, phd. Citation: orthopedics june 2011 - volume 34, issue 6: e172-e177; doi: 10. 3928/01477447-20110427-10. This prospective study aimed to present if simple method of single "coraclavicular" suture fixation with mersilene tape would maintain the reduction of the fracture, restore the coraclavicular space, and provide enough strength to keep reduction until union of the fractured site. From 2004 to 2006, 28 patients (n=28 male and n=10 female; mean age of 37. 9 years [ranged 19-71 years]) with acute, closed neer type iib distal clavicular fractures were treated with single coraclavicular suture fixation using mersilene tape. In the procedure, the mersilene tape was pass through the inferior base of the coracoid process and around the medial clavicular segment. Postoperatively, one patient experienced frozen shoulder (with pain) on the treated side which resolved after adequate rehabilitation, and another patient reported uncomfortable skin tenting due to subcutaneous protrusion of the suture node of the mersilene tape which resolved with simple surgical removal of the node using local anesthesia after bony union of the fracture site. Single coracoclavicular fixation with mersilene tape was effective in all patients with acute neer type iib distal clavicular fractures without any hardware, even in patients with comminuted distal fragments or osteoporosis. Mersilene tape maintained the reduction of the fracture and restored the coracoclavicular space, and it changed the pattern of the fracture from neer type ii to type i.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2018-77258 |
| MDR Report Key | 8091084 |
| Report Source | FOREIGN,LITERATURE |
| Date Received | 2018-11-20 |
| Date of Report | 2018-11-13 |
| Date Mfgr Received | 2018-11-13 |
| Date Added to Maude | 2018-11-20 |
| 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 | 2018-11-20 |
| 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 | 2018-11-20 |