MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-10-29 for ABDOMINAL BINDER (01)00749756611626(20)01(22)7828397826 A131056 manufactured by Deroyal Industries Inc.
[3901357]
Patient developed rash on abdomen where abdominal binder was located. This facility has had ongoing issues with this device. Multiple patients have been involved over approximately 8 months. Patients who have had c-sections and those who have had vaginal deliveries have been affected. The facility does not know why this is occurring. Some patients have required medical intervention for the rash that has developed. Patients with and without known allergies have been affected. ====================== manufacturer response for small/medium abdominal binder 9 inch, (brand not provided) (per site reporter). ====================== left a message and await a call back to return to manufacturer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3439620 |
| MDR Report Key | 3439620 |
| Date Received | 2013-10-29 |
| Date of Report | 2013-10-29 |
| Date of Event | 2013-10-23 |
| Report Date | 2013-10-29 |
| Date Reported to FDA | 2013-10-29 |
| Date Reported to Mfgr | 2013-10-31 |
| Date Added to Maude | 2013-10-31 |
| 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 | 3 |
| 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 | BINDER, ABDOMINAL |
| Product Code | FSD |
| Date Received | 2013-10-29 |
| Model Number | (01)00749756611626(20)01(22)7828397826 |
| Catalog Number | A131056 |
| Lot Number | 32839732 |
| ID Number | * |
| Device Availability | Y |
| Device Age | 1 DAY |
| 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 | 2013-10-29 |