MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-07-17 for ABDOMINAL BINDER * manufactured by Deroyal Industries.
[15810585]
Pt s/p c-section developed rash on abdomen two days after abdominal binder was in place. Md was called about rash and abdominal binder will not be reapplied to patient. Staff did not save the packaging so the lot and ref number are unavailable. However, this facility has had multiple similar problems with this device. Patients have developed a similar rash within 24-48 hours of placement of the abdominal binder. Previous product has been returned to the manufacturer. Staff and manufacturer do not know what is causing this problem.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3973227 |
| MDR Report Key | 3973227 |
| Date Received | 2014-07-17 |
| Date of Report | 2014-07-17 |
| Date of Event | 2014-07-16 |
| Report Date | 2014-07-17 |
| Date Reported to FDA | 2014-07-17 |
| Date Reported to Mfgr | 2014-08-01 |
| Date Added to Maude | 2014-08-01 |
| 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 | ABDOMINAL BINDER |
| Product Code | FSD |
| Date Received | 2014-07-17 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Age | 2 DAY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEROYAL INDUSTRIES |
| Manufacturer Address | 200 DEBUSK LANE POWELL TN 37849 US 37849 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-07-17 |