MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2010-01-06 for NOT AVAILABLE manufactured by Zimmer Orthopaedic Surgical Products.
[1449047]
It was reported that a zimmer shoulder sling caused a pt to have giant blisters and violent reaction from wearing the sling.
Patient Sequence No: 1, Text Type: D, B5
[8344695]
Incident was reported by pt's family (wife). Device was not returned to the manufacturer for eval. Hospital where pt received treatment was contacted ((b) (6) hospital (b) (6). However, hospital did not have any record of the reported incident.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1035617-2009-00035 |
| MDR Report Key | 1583896 |
| Report Source | 06 |
| Date Received | 2010-01-06 |
| Date of Report | 2009-12-07 |
| Date of Event | 2009-12-01 |
| Date Added to Maude | 2010-07-22 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | JOHN WATKINS |
| Manufacturer Street | 200 WEST OHIO AVENUE |
| Manufacturer City | DOVER OH 44622 |
| Manufacturer Country | US |
| Manufacturer Postal | 44622 |
| Manufacturer Phone | 3303649483 |
| Manufacturer G1 | ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS |
| Manufacturer Street | 2021 OLD MOUNTAIN RD. |
| Manufacturer City | STATESVILLE NC 28677 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 28677 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | ZIMMER SLING |
| Product Code | ILI |
| Date Received | 2010-01-06 |
| Model Number | NA |
| Catalog Number | NOT AVAILABLE |
| Lot Number | UNK |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS |
| Manufacturer Address | STATESVILLE NC US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-01-06 |