D
Patient 1
DOCTOR IMPLANTED EXPIRED MATERIAL INTO PATIENT IN 2008. THE PRODUCT WAS USED 6 MONTHS PAST ITS EXPIRATION DATE OF MARCH 2008.
MAUDE MDR 1236841
- MDR report key
- 1236841
- Report number
- 3004155681-2008-00001
- Event key
- 0
- Event type
- 3
- Date of event
- 2008-10-08
- Date received
- 2008-11-03
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- SUZANNE WOJCIK, SR DIR
- Address
- 1800 TRIPLETT BLVD AKRON OH 44306 US
- Phone
- 866-866-8669
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | THERIGRAFT PUTTY 5CC | BONE VOID FILLER | THERICS, LLC | MQV | 0107050 | NA | A06D05F | N | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2008-11-03 | 0 | 1. O |
Event Narratives#
N
Patient 1
DEVICE HAS BEEN IMPLANTED. LETTER WAS SENT IN 2/2008 TO DISTRIBUTOR INDICATING EXPIRY OF THE PRODUCTS IN THEIR POSSESSION. THIS LOT NUMBER WAS INCLUDED IN THAT LIST.