MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2013-11-21 for DEROYAL A131067 manufactured by Deroyal Guatemala.
[4096010]
The hospital reported that they have had multiple events with the abdominal binder causing a rash on stomach in the last 6 months. Product states latex free. The facility reports that this type of reaction has been seen in patients with c-sections as well as vaginal deliveries; thus, the staff does not believe that there is a reaction to the skin prep used for c-section deliveries since the prep is not used in vaginal delivery. Also, the reaction occurs on areas where skin prep was not used. Patients with and without known allergies have been affected.
Patient Sequence No: 1, Text Type: D, B5
[11475192]
Deroyal: the bill of material for the reported device was reviewed and no material changes have been made. The abdominal binder is not made with natural rubber latex. A root cause could not be determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005225477-2013-00024 |
| MDR Report Key | 3542413 |
| Report Source | 00 |
| Date Received | 2013-11-21 |
| Date of Report | 2013-10-24 |
| Date of Event | 2013-07-23 |
| Date Facility Aware | 2013-07-23 |
| Report Date | 2013-10-24 |
| Date Reported to FDA | 2013-09-23 |
| Date Mfgr Received | 2013-10-24 |
| Date Added to Maude | 2014-01-15 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 200 DEBUSK LN |
| Manufacturer City | POWELL TN 37849 |
| Manufacturer Country | US |
| Manufacturer Postal | 37849 |
| Manufacturer Phone | 8659387828 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEROYAL |
| Product Code | FSD |
| Date Received | 2013-11-21 |
| Returned To Mfg | 2013-11-08 |
| Catalog Number | A131067 |
| 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 | 2013-11-21 |