MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2013-06-17 for DEROYAL 9211-03 manufactured by Deroyal Guatemala.
[3465521]
The end user reported that the traction unit tore apart while the patient was in traction, causing cable to snap back into patient's face.
Patient Sequence No: 1, Text Type: D, B5
[10864825]
Describe event or problem: the end user reported that the traction unit tore apart while the patient was in traction, causing cable to snap back into patients face. Deroyal: the reported device is not available for evaluation. The investigation is in process and the root cause has not been determined at this current time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005225477-2013-00009 |
| MDR Report Key | 3190396 |
| Report Source | 04 |
| Date Received | 2013-06-17 |
| Date of Report | 2013-05-28 |
| Date of Event | 2013-05-24 |
| Date Facility Aware | 2013-05-24 |
| Report Date | 2013-05-28 |
| Date Reported to Mfgr | 2013-05-28 |
| Date Mfgr Received | 2013-05-28 |
| Date Added to Maude | 2013-06-28 |
| 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 37849 |
| Manufacturer Country | US |
| Manufacturer Postal | 37849 |
| Manufacturer Phone | 8659387828 |
| Manufacturer G1 | DEROYAL GUATEMALA |
| Manufacturer Street | KM 20.5 CARRETERA A VILLA CANALES VILLA CANALES |
| Manufacturer City | GUATEMALA |
| Manufacturer Country | GT |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEROYAL |
| Generic Name | IQI - ORTHOSIS, LIMB BRACE |
| Product Code | HSS |
| Date Received | 2013-06-17 |
| Catalog Number | 9211-03 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2013-06-17 |