MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2007-05-11 for DEROYAL ELBOW IMMOBILIZER M2035 manufactured by Deroyal Industries, Inc..
[645651]
It was reported that a pt experienced puncture wounds while wearing an elbow immobilizer.
Patient Sequence No: 1, Text Type: D, B5
[7974081]
The incident device was not returned for inspection and evaluation and no lot number was given for the incident device. The mfr inspected elbow immobilizers from work in progress and no visual defects were found. Mfg was per specifications. Add'l info was requested from the user facility regarding who prescribed the pt positioner, how it was applied to the pt by the healthcare worker and what f/u protocol was followed to care for the pt while he/she was wearing the elbow immobilizer. As of the date of this report, none of the requested info has been rec'd from the facility. The mfr has not been able to determine the root cause of this reported incident with the initial info provided. If add'l pertinent info regarding this incident is rec'd, a supplemental report will be submitted at that time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003598201-2007-00002 |
| MDR Report Key | 851589 |
| Report Source | 05,07 |
| Date Received | 2007-05-11 |
| Date of Report | 2007-05-07 |
| Report Date | 2007-05-07 |
| Date Reported to FDA | 2007-05-07 |
| Date Reported to Mfgr | 2007-03-19 |
| Date Mfgr Received | 2007-03-19 |
| Date Added to Maude | 2007-05-18 |
| 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 | 3 |
| 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 | * |
| Manufacturer G1 | DEROYAL GUATEMALA |
| Manufacturer Street | 1 A AVENIDA 3-32, ZONA 1 BOCA DEL MONTE |
| Manufacturer City | VILLA CANALES, CA |
| Manufacturer Country | GT |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEROYAL ELBOW IMMOBILIZER |
| Generic Name | PATIENT POSITIONER |
| Product Code | ILI |
| Date Received | 2007-05-11 |
| Model Number | NA |
| Catalog Number | M2035 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | UNKNOWN |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 838229 |
| Manufacturer | DEROYAL INDUSTRIES, INC. |
| Manufacturer Address | * POWELL TN 37849 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-05-11 |