MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2007-12-21 for SURECUT ADENOID CURETTE R5012 manufactured by .
[2134623]
.
Patient Sequence No: 1, Text Type: D, B5
[9149426]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1017294-2006-00034 |
| MDR Report Key | 2194393 |
| Report Source | 05,06 |
| Date Received | 2007-12-21 |
| Date Mfgr Received | 2006-01-10 |
| Device Manufacturer Date | 2005-03-09 |
| Date Added to Maude | 2011-08-16 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | BEVERLY SCHANER |
| Manufacturer Street | 11311 CONCEPT BLVD. |
| Manufacturer City | LARGO FL 33773 |
| Manufacturer Country | US |
| Manufacturer Postal | 33773 |
| Manufacturer Phone | 7273995169 |
| Manufacturer G1 | LINVATEC CORP. |
| Manufacturer Street | 11311 CONCEPT BLVD. |
| Manufacturer City | LARGO FL 33773 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33773 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SURECUT ADENOID CURETTE |
| Generic Name | ADENOID CURETTE, SIZE 2 |
| Product Code | KBJ |
| Date Received | 2007-12-21 |
| Model Number | NA |
| Catalog Number | R5012 |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-12-21 |