MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2013-07-18 for DEROYAL 13661056 manufactured by Deroyal Guatemala.
[3617983]
Pt reported that they had a severe reaction to the abdominal binder.
Patient Sequence No: 1, Text Type: D, B5
[10958329]
Describe event or problem: pt reported that they had a severe reaction to the abdominal binder. 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. The appropriate level of skin contact biocompatibility on the materials was confirmed. Sensitization, irritation, cytotoxicity, and latex protein concentration testing were successfully completed and passed. Furthermore, the product does not contain natural rubber latex.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005225477-2013-00011 |
| MDR Report Key | 3246701 |
| Report Source | 00 |
| Date Received | 2013-07-18 |
| Date of Report | 2013-06-28 |
| Date of Event | 2013-06-28 |
| Date Facility Aware | 2013-06-28 |
| Report Date | 2013-06-28 |
| Date Reported to Mfgr | 2013-06-28 |
| Date Mfgr Received | 2013-06-28 |
| Device Manufacturer Date | 2012-10-01 |
| Date Added to Maude | 2013-07-31 |
| 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 |
| 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 | DRESSING, COMPRESSION |
| Product Code | MHW |
| Date Received | 2013-07-18 |
| Returned To Mfg | 2013-07-15 |
| Catalog Number | 13661056 |
| 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 | 2013-07-18 |