FDA Adverse Event
Summary report: N
ANTI FOG SURGICAL MASK
MDR report key: 61504
·
Received January 10, 1997
Report
- Report Number
- MW1010537
- Date Received
- January 10, 1997
- Manufacturer
- TECNOL MEDICAL PRODUCTS, INC.
- Product Code
- FXX
- Report Source
- Voluntary report
- Reporter Location
- WA, US
- Reporter Occupation
- PHARMACIST
Narratives
Description of Event or Problem · 1
THE PROBLEM DESCRIBED IN THE COMPLAINT WAS THAT THE MASK HAD AN ODOR. CO HAS REVIEWED THE ODOR PROBLEM WITH MFG AND HAS CONDUCTED MORE TESTING, CO HAS DETERMINED THAT A BAD LOT OF MATERIAL WAS RECEIVED. THE RAW MATERIAL WAS ISOLATED AND REMOVED FROM THE PRODUCTION FLOOR. INCREASED INSPECTION HAS BEEN MADE OF ALL RAW MATERIALS TO DETECT ANY POSSIBLE ODOR AND TO PREVENT IT FROM BEING USED IN PRODUCTION. NEW RAW MATERIALS HAVE BEEN SOURCED AND ORDERED FOR NEW MASKS PRODUCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ANTI FOG SURGICAL MASK | SURGICAL MASK | FXX | TECNOL MEDICAL PRODUCTS, INC. | * | PQR # 6535T180 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |