MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-08-09 for DEROYAL A131056 manufactured by Deroyal Guatemala.
[3711512]
Abdominal binder caused itching and rash. Rash light pink without blisters. Rash was all over the area where binder was touching skin. This facility has had more than 7 similar events with this product in the last 5 months. Product states latex free. The facility reports this type of reaction has been seen in pts with c-sections as well as vaginal deliveries; thus staff does not believe that there is a reaction to the skin prep used for c-section deliveries because the prep is not used in a vaginal delivery. Also, staff has stated in previous incidents hat the rash occurs on areas which does not have the skin prep but does have contact with the binder. Pts with and without known allergies have been affected. The manufacturer has been notified. We checked with our surgical unit because they use quite a few abdominal binders nd they have not heard of any concerns regarding rash. Patients in the surgical unit would have similar use of this device. Also, there are pts in the surgical unit who have and who have not had exposure to the same brand of skin prep as the pts on the other unit. The storage procedure/process for both nursing units is identical: storage and transportation of the devices are not believed to be contributing factors in these events.
Patient Sequence No: 1, Text Type: D, B5
[11067958]
Deroyal: the bill of material for the components of the product was reviewed and no material changes to the components were identified for the lot number reported. Furthermore, the product does not contain natural rubber latex.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005225477-2013-00016 |
| MDR Report Key | 3300841 |
| Report Source | 06 |
| Date Received | 2013-08-09 |
| Date of Report | 2013-07-17 |
| Date of Event | 2013-07-05 |
| Date Facility Aware | 2013-07-05 |
| Report Date | 2013-07-17 |
| Date Reported to FDA | 2013-07-09 |
| Date Reported to Mfgr | 2013-07-17 |
| Date Mfgr Received | 2013-07-17 |
| Device Manufacturer Date | 2013-05-01 |
| Date Added to Maude | 2013-09-03 |
| 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 | 8659387828 |
| Manufacturer G1 | DEROYAL GUATEMALA |
| Manufacturer Street | KM 20.5 CARRETERA A VILLA CANALES VILL CANALES |
| Manufacturer City | GUATEMLA |
| Manufacturer Country | GT |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEROYAL |
| Generic Name | MHW - DRESSING, COMPRESSION |
| Product Code | MHW |
| Date Received | 2013-08-09 |
| Returned To Mfg | 2013-07-22 |
| Catalog Number | A131056 |
| Lot Number | 31622021 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEROYAL GUATEMALA |
| Manufacturer Address | GT |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-08-09 |