MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2011-07-01 for ASCENSION DRUJ manufactured by Ascension Orthopedics, Inc..
[2073908]
It was reported that a pt had a druj device removed because the pt was experiencing pain.
Patient Sequence No: 1, Text Type: D, B5
[9202462]
Little info about the event has been provided. The investigation is ongoing. If add'l info is collected/determined, a supplemental report will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1651501-2011-00053 |
| MDR Report Key | 2156030 |
| Report Source | 08 |
| Date Received | 2011-07-01 |
| Date of Report | 2011-07-01 |
| Date of Event | 2011-06-03 |
| Date Mfgr Received | 2011-06-03 |
| Date Added to Maude | 2011-07-13 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | KEN THOMA |
| Manufacturer Street | 8700 CAMERON RD. |
| Manufacturer City | AUSTIN TX 78754 |
| Manufacturer Country | US |
| Manufacturer Postal | 78754 |
| Manufacturer Phone | 5128365001 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ASCENSION DRUJ |
| Generic Name | WRIST JOINT ULNAR (HEMI-WRIST) PROSTHESIS |
| Product Code | KXE |
| Date Received | 2011-07-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASCENSION ORTHOPEDICS, INC. |
| Manufacturer Address | 8700 CAMERON RD. AUSTIN TX 78754 US 78754 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-07-01 |