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 A131067 manufactured by Deroyal Guatemala.
[3607699]
Per mother baby nurse: "velcro binder causing itchy red flattish rash where binder covered on abdomen". Rash was nonraised. Binder was removed and replaced with soft stretchy binder (different product). This facility has had more than 9 similar events with this product in the last 5 month. Product states latex free. The facility reports this type of reaction has been seen in patients 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 vaginal delivery. Also, staff has stated in previous incidents that the rash occurs on areas which does not have the skin prep but does have contact with the binder. Patient with and without known allergies have been affected. The manufacturer has been notified. They are unaware of any other complaints like this. We checked with our surgical unit because they use quite a few abdominal binders and they have not heard of any concerns regarding rash. Patients in the surgical unit would have similar use of this device. Also, there are patients in the surgical both who have and who have not had exposure to the same brand of skin prep as the patients on the other nursing unit. The storage procedure/process for both nursing units and is identical: storage and transportation of the device are not believed to be contributing factors in these events.
Patient Sequence No: 1, Text Type: D, B5
[11053218]
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 | 3005225477-2013-00014 |
| MDR Report Key | 3290268 |
| 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 | 2013-06-01 |
| Date Added to Maude | 2013-08-26 |
| 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 |
| Manufacturer City | VILL CANALES |
| 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 | A131067 |
| Lot Number | 31735501 |
| 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 |