MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07,company representative, report with the FDA on 2013-07-13 for SHEEHY KNIFE CURETTE,2MM DIAM 1/EA 3722038 manufactured by Medtronic Xomed, Inc..
[3572382]
It was reported while the doctor was performing a mastoid the sheehy knife curette broke in use. He was able to see it with microscope and retrieved the broken tip. No harm done to the patient.
Patient Sequence No: 1, Text Type: D, B5
[10898688]
This device is used for therapeutic purposes. (b)(4). Product has been returned, evaluation expected.
Patient Sequence No: 1, Text Type: N, H10
[32237522]
The device was returned and reviewed by quality engineer. Received one (1) sample without the original packaging / label. The condition of the device showed possible customer use as the device was found damaged. From visual evaluation, the semi-sharp edge of the knife curette was found broken and the broken piece was not returned with the device. The broken edge was observed under magnification and appeared to be a clean break. The breakage possibly occurred due to excessive customer handling / use of the device. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[102468809]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045254-2013-00455 |
| MDR Report Key | 3225544 |
| Report Source | 06,07,COMPANY REPRESENTATIVE, |
| Date Received | 2013-07-13 |
| Date of Report | 2013-06-20 |
| Date of Event | 2013-06-20 |
| Date Mfgr Received | 2013-07-19 |
| Date Added to Maude | 2013-08-02 |
| 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 | HOSPITAL SERVICE TECHNICIAN |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CHRISTY CAIN |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE N |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328353 |
| Manufacturer G1 | MEDTRONIC XOMED, INC |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE N |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32216 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SHEEHY KNIFE CURETTE,2MM DIAM 1/EA |
| Generic Name | CURETTE, EAR |
| Product Code | JYG |
| Date Received | 2013-07-13 |
| Returned To Mfg | 2013-07-08 |
| Model Number | 3722038 |
| Catalog Number | 3722038 |
| Lot Number | NOT PROVIDED |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC XOMED, INC. |
| Manufacturer Address | 6743 SOUTHPOINT DRIVE NORTH JACKSONVILLE FL 32216 US 32216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-07-13 |