FDA Adverse Event
Summary report: N
DEAN SCISSORS S-9
MDR report key: 13035
·
Received April 22, 1994
Report
- Report Number
- MW4000360
- Date Received
- April 22, 1994
- Report Date
- September 7, 1993
- Manufacturer
- HUFRIEDY MFG CO., INC.
- Product Code
- EGN
- Report Source
- Voluntary report
- Reporter Location
- MI, US
- Reporter Occupation
- DENTIST
Narratives
Description of Event or Problem · 1
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DEAN SCISSORS S-9 | EGN | HUFRIEDY MFG CO., INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |