MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2014-07-25 for SHOULDER IMMOBILIZER W/CLOTH SWATHE, M 9001-03 manufactured by Deroyal Guatemala.
[5087604]
Pt developed a rash while using this product. The doctor asked to be informed of the materials the product is made from so she can inform the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005225477-2014-00017 |
| MDR Report Key | 4168990 |
| Report Source | 04 |
| Date Received | 2014-07-25 |
| Date of Report | 2014-07-24 |
| Date of Event | 2014-07-03 |
| Date Facility Aware | 2014-07-03 |
| Report Date | 2014-07-24 |
| Date Mfgr Received | 2014-07-03 |
| Date Added to Maude | 2014-10-17 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 200 DEBUSK LN |
| Manufacturer City | POWELL TN 37849 |
| Manufacturer Country | US |
| Manufacturer Postal | 37849 |
| Manufacturer Phone | 8653622333 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SHOULDER IMMOBILIZER W/CLOTH SWATHE, M |
| Generic Name | SLING, ARM |
| Product Code | ILI |
| Date Received | 2014-07-25 |
| Catalog Number | 9001-03 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEROYAL GUATEMALA |
| Manufacturer Address | KM 20.5 CARRETERA A VILLA CANALES CILLA CANALES GT |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-07-25 |