MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2009-09-03 for UNK DEPUY HAND TABLE manufactured by Depuy Orthopaedics, Inc..
[1149445]
Suit papers allege that during surgery for carpel tunnel release on the right hand, the pt's elbow "was burned in two places by what was believed to be the depuy hand table. "
Patient Sequence No: 1, Text Type: D, B5
[8412079]
Examination was possible, as the product was not returned. The investigation was limited to review of the information provided, as the part and lot number required to review the device history records was not provided. The investigation could not draw any conclusions about the reported event. Based on the investigation, the need for corrective action is not indicated. Depuy considers the investigation closed. Should any add'l info be received to change the outcome of the performed investigation, the complaint will be re-opened.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1818910-2009-04706 |
| MDR Report Key | 1464320 |
| Report Source | 00 |
| Date Received | 2009-09-03 |
| Date of Report | 2009-08-06 |
| Date Mfgr Received | 2009-08-10 |
| Date Added to Maude | 2009-09-11 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | KATHERINE SEPPA, MGR |
| Manufacturer Street | 700 ORTHOPAEDIC DR. |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810988 |
| Manufacturer Phone | 5743727333 |
| Manufacturer G1 | DEPUY ORTHOPAEDICS, INC. |
| Manufacturer Street | 700 ORTHOPAEDIC DR. |
| Manufacturer City | WARSAW IN 46581098 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46581 0988 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNK DEPUY HAND TABLE |
| Generic Name | INSTRUMENTATION |
| Product Code | BWN |
| Date Received | 2009-09-03 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY ORTHOPAEDICS, INC. |
| Manufacturer Address | 700 ORTHOPAEDIC DR. WARSAW IN 46581098 US 46581 0988 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-09-03 |