MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-04-22 for DEAN SCISSORS S-9 manufactured by Hufriedy Mfg Co., Inc..
[21959922]
Scissors break upon opening in pt's mouth. The blade snaps off at joint where screw attaches the scissors together. This drops in pt's mouth, (a 2" blade and the screw). The surgeon has been using the instruments since 3/93. Complainant ordered a dozen instruments in march of which 6 have broken. Dental supply replaced them with a dozen more scissors. Six of these have also been defective. The complainant filed a complaint directly to the mfr. Complainant added that he has used many types of dental instruments mfg by co and has never experienced a problem until now.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4000360 |
| MDR Report Key | 13035 |
| Date Received | 1994-04-22 |
| Date of Report | 1993-09-07 |
| Date Added to Maude | 1994-05-03 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEAN SCISSORS S-9 |
| Product Code | EGN |
| Date Received | 1994-04-22 |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 13033 |
| Manufacturer | HUFRIEDY MFG CO., INC. |
| Manufacturer Address | CHICAGO IL 60618 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1994-04-22 |