D
Patient 1
.
MAUDE MDR 2194393
- MDR report key
- 2194393
- Report number
- 1017294-2006-00034
- Event key
- 0
- Event type
- 3
- Date received
- 2007-12-21
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 0
- Initial report to FDA
- 0
- Event location
- 0
Manufacturer Contact#
- Contact
- BEVERLY SCHANER
- Address
- 11311 CONCEPT BLVD. LARGO FL 33773 US
- Phone
- 727-727-7273
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | SURECUT ADENOID CURETTE | ADENOID CURETTE, SIZE 2 | KBJ | NA | R5012 | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2007-12-21 | 0 |
Event Narratives#
N
Patient 1
MEDWATCH FORM WAS RECEIVED, HOWEVER, ONLY FRONT PAGE, PAGE 2 WAS NOT RECEIVED FROM USER FACILITY. NO USER FACILITY REGISTRATION NUMBER ON MEDWATCH FORM. USER FACILITY MEDWATCH FORM ATTACHED. INVESTIGATION RESULT: THE CURETTE WAS RETURNED FOR EVAL. A VISUAL EXAMINATION OF THE DEVICE FOUND THERE WAS NO BLADE INSTALLED IN THE CURETTE. IN ADDITION, THE SLOT WHERE THE BLADE SHOULD BE INSTALLED HAD EXCESSIVE FLASH (EXCESS MATERIAL) ROLLED OVER WERE THE BLADE SHOULD HAVE BEEN INSERTED. THIS EXAMINATION FINDS THAT THE BLADE MAY NOT HAVE BEEN INSTALLED. A REVIEW OF THE OTHER COMPLAINTS SHOWED THERE IS NO OTHER COMPLAINTS FOR THIS DEVICE AND TYPE OF FAILURE.