N
Patient 1
(B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
MAUDE MDR 8269048
- MDR report key
- 8269048
- Report number
- 1818910-2019-81859
- Event key
- 0
- Event type
- 3
- Date of event
- 2019-01-03
- Date received
- 2019-01-22
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MS. KARA DITTY-BOVARD
- Address
- 1210 WARD AVENUE WEST CHESTER IN 19380 US
- Phone
- 610-610-6103
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | STAND CUP TRIAL D42 +3MM | EXTREMITY INSTRUMENTS : HUMERAL TRIALS | DEPUY FRANCE SAS 3003895575 | LHX | 230742403 | 5219041 | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2019-01-22 | 0 |
Event Narratives#
D
Patient 1
IT WAS REPORTED THAT THE HUMERAL CUP TRIALS HAVE SHAVING OF PLASTIC COMING OFF OF THEM. HAD TO OPEN THREE DIFFERENT TRAYS FOR CASE. ALL WENT WELL AND NOTHING LEFT IN PATIENT.
N
Patient 1
PRODUCT COMPLAINT # : (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.