MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 1997-12-12 for ULTRA SLING 11-0138-2-13130 manufactured by Smith & Nephew, Inc..
[21385626]
On november 10, 1997, co was notified of an injury that resulted in neurological paralysis to the patients' shoulder on the left side. More specifically, the injury was within the region of the "musculus trapezius" and "musculus sternocleidomastoideus". It was reported that the two inch pad and trap, used on the subject arm sling, allegedly impinged on the subject patients' shoulder nerve. A request for more detailed information has been submitted to the reporter.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2026088-1997-00003 |
| MDR Report Key | 138035 |
| Report Source | 08 |
| Date Received | 1997-12-12 |
| Date of Report | 1997-12-08 |
| Date of Event | 1997-01-01 |
| Date Mfgr Received | 1997-11-10 |
| Date Added to Maude | 1997-12-17 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTRA SLING |
| Generic Name | ARM SLING |
| Product Code | ILI |
| Date Received | 1997-12-12 |
| Model Number | 11-0138-2-13130 |
| Catalog Number | 11-0138-2-13130 |
| Lot Number | NI |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 134810 |
| Manufacturer | SMITH & NEPHEW, INC. |
| Manufacturer Address | 2777 LOKER AVE., WEST CARLSBAD CA 92008 US |
| Baseline Brand Name | ULTRA SLING, SMALL |
| Baseline Generic Name | ULTRA SLING |
| Baseline Model No | 11-0138-2-13130 |
| Baseline Catalog No | 11-0138-2-13130 |
| Baseline ID | ARM SLING |
| Baseline Device Family | ULTRA SLING |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-12-12 |