MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2013-01-08 for FASHION ARM SLING, LARGE BOX 10 00-1796-013-10 manufactured by Zimmer Surgical.
[3217041]
It was reported that the zimmer arm sling was irritating to a patient as the arm sling was reported to be made from a different material. No additional clinical information was received prior to this report.
Patient Sequence No: 1, Text Type: D, B5
[10425902]
The device was not returned to the manufacturer. The investigation was not completed at the time of this report. A follow up medwatch will be submitted once the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1526350-2013-00009 |
| MDR Report Key | 2912795 |
| Report Source | 05,08 |
| Date Received | 2013-01-08 |
| Date of Report | 2012-12-10 |
| Date of Event | 2012-12-01 |
| Date Mfgr Received | 2012-12-10 |
| Date Added to Maude | 2013-01-15 |
| 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 | CINDY DICKEY |
| Manufacturer Street | 200 WEST OHIO AVE. |
| Manufacturer City | DOVER OH 44622 |
| Manufacturer Country | US |
| Manufacturer Postal | 44622 |
| Manufacturer Phone | 3303438801 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FASHION ARM SLING, LARGE BOX 10 |
| Generic Name | FASHION ARM SLING, LARGE BOX 10 |
| Product Code | ILI |
| Date Received | 2013-01-08 |
| Model Number | NA |
| Catalog Number | 00-1796-013-10 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER SURGICAL |
| Manufacturer Address | 200 WEST OHIO AVE. DOVER OH 44622 US 44622 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-01-08 |