MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-08-08 for DEROYAL ABDOMINAL BINDER, 9IN, S/M A131056 manufactured by Deroyal Guatemala.
[4737270]
Patient developed a reaction (rash) on the abdomen and back where the abdominal binder had been in direct contact with the patient's skin. Patient complained of itchy rash on her abdomen and on her back. The rash was in the shape of the binder; patient said that the doctor knows about it and gave her a and d ointment for it. Patient given benadryl p. O. For the itching. The facility has had ongoing issues with this device over the last year. Rashes have developed after the abdominal binder is placed. Patients in all areas of the facility where the product is used have been affected. There is no apparent visual defect to the device. The rash develops within 24 hours after placement on the patient. Affected patients are not allergic to latex and have no previously reported allergies. Some patients have required medical intervention for the rash. The manufacturer has been notified and product has been returned. Contributing factors for the rash have not been able to be determined. The devices are stored in temperature controlled environments and are sealed in their individual packages until needed.
Patient Sequence No: 1, Text Type: D, B5
[11996493]
The complaint was received via fda on 07/29/2014. We have contacted the customer, 08/07/2014 to see if product is still available for evaluation. No further information is available at this time. Will provide follow ups if information becomes available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005225477-2014-00018 |
| MDR Report Key | 4047692 |
| Report Source | 05 |
| Date Received | 2014-08-08 |
| Date of Report | 2014-08-07 |
| Date of Event | 2014-06-12 |
| Date Facility Aware | 2014-06-12 |
| Report Date | 2014-08-07 |
| Date Reported to FDA | 2014-07-18 |
| Date Mfgr Received | 2014-07-29 |
| Device Manufacturer Date | 2014-03-01 |
| Date Added to Maude | 2014-09-08 |
| 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, 9IN, S/M |
| Generic Name | BINDER, ABDOMINAL |
| Product Code | FSD |
| Date Received | 2014-08-08 |
| Catalog Number | A131056 |
| Lot Number | 35159679 |
| 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 | KM 20.5 CARRETERA A VILLA CANALES VILLA CANALES GT |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-08-08 |