MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-08-15 for ABDOMINAL BINDER * manufactured by Deroyal Industries Inc..
[4846001]
Patient developed red, raised, itchy rash where abdominal binder was. This facility has experienced multiple similar problems with this device over the last year. The manufacturer has been contacted and product has been provided to the manufacturer. As of this report, the cause of the problem remains unknown. Patients with no known allergy to latex are affected. The manufacturer has shared that there is no latex in this device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4016709 |
| MDR Report Key | 4016709 |
| Date Received | 2014-08-15 |
| Date of Report | 2014-08-15 |
| Date of Event | 2014-07-25 |
| Report Date | 2014-08-15 |
| Date Reported to FDA | 2014-08-15 |
| Date Reported to Mfgr | 2014-08-18 |
| Date Added to Maude | 2014-08-18 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ABDOMINAL BINDER |
| Generic Name | ABDOMINAL BINDER |
| Product Code | FSD |
| Date Received | 2014-08-15 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEROYAL INDUSTRIES INC. |
| Manufacturer Address | 200 DEBUSK LANE POWELL TN 37849 US 37849 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-08-15 |