MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,07 report with the FDA on 2011-12-06 for FIRST CHOICE HEAD 14.5-STEM 5.5 DRUJ-610-1455-WW manufactured by Ascension Orthopedics.
[2433973]
The reporter stated the pt called and said she wanted a sample of the ulnar head replacement placed in her wrist in (b)(6) 2011. She stated that she started having a rash on her wrist that moved associated with swelling and pain. They tried several things including changing her cast and topical applications which have not changed her condition. She has taken an allergy test and nickel reactions have been inconclusive. (b)(4). She is wanting to get a disk from us so that her doctor can use it to test her with. She volunteered that she has had 4 previous operations on the wrist and two cortisone shots with (b)(6) prior to the implant. Her other wrist has also been operated on using a different procedure (bone replacement).
Patient Sequence No: 1, Text Type: D, B5
[9646978]
To date, the device involved in the reported incident has not been received for eval. An investigation has been initiated based upon the reported info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1651501-2011-00090 |
| MDR Report Key | 2451045 |
| Report Source | 04,07 |
| Date Received | 2011-12-06 |
| Date of Report | 2011-12-06 |
| Date of Event | 2011-11-18 |
| Date Mfgr Received | 2011-11-18 |
| Date Added to Maude | 2012-07-19 |
| 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 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARIA D'AGOSTINO |
| Manufacturer Street | 315 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FIRST CHOICE HEAD 14.5-STEM 5.5 |
| Generic Name | FIRSTCHOICE DRUJ |
| Product Code | KXE |
| Date Received | 2011-12-06 |
| Catalog Number | DRUJ-610-1455-WW |
| Lot Number | 10-2525 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASCENSION ORTHOPEDICS |
| Manufacturer Address | AUSTIN TX 78754 US 78754 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-12-06 |