MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2009-11-07 for DISP DERMAL CURETTES 4MM 33-54 manufactured by .
[17733290]
A registered nurse was removing individual packages of sterile disposable curettes from the box. While removing the products, she cut her right index finger on a curette, requiring 4 stitches.
Patient Sequence No: 1, Text Type: D, B5
[17984101]
To date, the device involved in the reported incident has not been received for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523190-2009-00003 |
| MDR Report Key | 1553155 |
| Report Source | 06 |
| Date Received | 2009-11-07 |
| Date of Report | 2009-12-07 |
| Date Mfgr Received | 2009-12-01 |
| Date Added to Maude | 2011-03-30 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | SANDRA LEE, RN, BSM |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099366828 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DISP DERMAL CURETTES 4MM |
| Generic Name | M3 - DERMAL |
| Product Code | JYG |
| Date Received | 2009-11-07 |
| Catalog Number | 33-54 |
| Lot Number | 081006 |
| Device Expiration Date | 2013-10-20 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-11-07 |