MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-04-22 for DEROYAL A131056 manufactured by Deroyal Guatemala.
[3454130]
The hospital reported that they are having several patients get bad reactions to the abdominal binder. Patients have broke out in red blotches and there was one patient that got hives. They had to give this patient steroid cream and benadryl. It could be the binder or the skin prep causing the problem.
Patient Sequence No: 1, Text Type: D, B5
[10742277]
Deroyal: the defective samples were not returned to the manufacturer. The abdominal binder is latex free and has had no new material changes. A root cause could not be determined from the information available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005225477-2013-00003 |
| MDR Report Key | 3130986 |
| Report Source | 06 |
| Date Received | 2013-04-22 |
| Date of Report | 2013-03-21 |
| Date of Event | 2013-03-21 |
| Date Facility Aware | 2013-03-21 |
| Report Date | 2013-03-21 |
| Date Reported to Mfgr | 2013-03-21 |
| Date Mfgr Received | 2013-03-21 |
| Date Added to Maude | 2013-05-31 |
| 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 | 0 |
| 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 | 8659387828 |
| Manufacturer G1 | DEROYAL GUATEMALA |
| Manufacturer Street | KM 20.5 CARRETERA A VILLA CANALES VILLA CANALES |
| Manufacturer City | GUATEMALA |
| Manufacturer Country | GT |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEROYAL |
| Product Code | FSD |
| Date Received | 2013-04-22 |
| Catalog Number | A131056 |
| 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 | GT |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-04-22 |