MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-07-02 for ABDOMINAL BINDER * A131067 manufactured by Deroyal Industries, Inc..
[3653009]
Abdominal binder caused maculopapular rash on patient's skin. Binder removed. Pt required benadryl and hydrocortisone. This facility has had more than 6 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 patients with c-sections as well as vaginal deliveries; thus, staff do 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 have stated in previous incidents that the rash occurs on areas which does not have the skin prep but does have contact with the binder. What was the original intended procedure? Abdominal wall protection/ support. Device #1is this a laboratory device or laboratory test? No.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3215398 |
| MDR Report Key | 3215398 |
| Date Received | 2013-07-02 |
| Date of Report | 2013-07-02 |
| Date of Event | 2013-07-01 |
| Report Date | 2013-07-02 |
| Date Reported to FDA | 2013-07-02 |
| Date Reported to Mfgr | 2013-07-10 |
| Date Added to Maude | 2013-07-10 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ABDOMINAL BINDER |
| Generic Name | BINDER, ABDOMINAL |
| Product Code | FSD |
| Date Received | 2013-07-02 |
| Model Number | * |
| Catalog Number | A131067 |
| Lot Number | 31981358 |
| ID Number | * |
| Device Availability | N |
| Device Age | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEROYAL INDUSTRIES, INC. |
| Manufacturer Address | 200 DEBUSK LANE POWELL TN 37849 US 37849 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-07-02 |