MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-06-03 for DEROYAL ABDOMINAL BINDER A131067 manufactured by Deroyal Guatemala.
[4557152]
Patient developed rash from abdominal binder. This facility has had ongoing issues with the device. Rashes have developed after the abdominal binder is placed on both c-section and vag delivery patients. This product also is used at this facility in the surgical unit. Until recently, surgical patients had not been affected. However, one case of a surgical patient with a similar event did happen recently. Affected patients are not allergic to latex and have no previously reported allergies. Some patients have required medical intervention for the rash.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005225477-2014-00013 |
| MDR Report Key | 3957948 |
| Report Source | 05 |
| Date Received | 2014-06-03 |
| Date of Report | 2014-06-02 |
| Date of Event | 2014-05-13 |
| Date Facility Aware | 2014-05-13 |
| Report Date | 2014-06-02 |
| Date Mfgr Received | 2014-05-13 |
| Device Manufacturer Date | 2013-12-01 |
| Date Added to Maude | 2014-07-31 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 200 DEBUSK LANE |
| 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 | DEROYAL ABDOMINAL BINDER |
| Generic Name | BINDER, ABDOMINAL |
| Product Code | FSD |
| Date Received | 2014-06-03 |
| Catalog Number | A131067 |
| Lot Number | 33405670 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEROYAL GUATEMALA |
| Manufacturer Address | KM 20.5 CARRETERA A VILLA CANALES VILLA CANALES GT |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-06-03 |