MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2013-05-13 for DEROYAL 9013-00 manufactured by Deroyal Guatemala.
[3500897]
The end user reported that the sling and swathe caused severe contact dermatitis where it came into contact with her skin after it had been fitted to limit arm movement status post reduction of a shoulder dislocation.
Patient Sequence No: 1, Text Type: D, B5
[10726425]
Deroyal: this device is not made of natural rubber latex. It is constructed of nylon loop laminated to polyester polyurethane foam. The root cause could not be determined from the analysis of device materials.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005225477-2013-00005 |
| MDR Report Key | 3116085 |
| Report Source | 00 |
| Date Received | 2013-05-13 |
| Date of Report | 2013-04-23 |
| Date of Event | 2013-04-23 |
| Date Facility Aware | 2013-04-23 |
| Report Date | 2013-04-23 |
| Date Reported to Mfgr | 2013-04-23 |
| Date Mfgr Received | 2013-04-23 |
| Date Added to Maude | 2013-05-23 |
| 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 LANE |
| Manufacturer City | POWELL TN 37921 |
| Manufacturer Country | US |
| Manufacturer Postal | 37921 |
| Manufacturer Phone | 8659387828 |
| Manufacturer G1 | DEROYAL GUATEMALA |
| Manufacturer Street | KM 20.5 CARRETERA A VILLA CANALES |
| Manufacturer City | VILLA CANALES |
| Manufacturer Country | GT |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEROYAL |
| Generic Name | ILI - SLING, ARM |
| Product Code | ILI |
| Date Received | 2013-05-13 |
| Catalog Number | 9013-00 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEROYAL GUATEMALA |
| Manufacturer Address | GT |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-05-13 |