MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-11-20 for PARFIN CUTTER/DISPENSER PM 901 (P1150-11) manufactured by Thermo Seperation Products.
[13219]
Employee cut finger on blade of parafilm cutter. The cut required eight (8) stitches.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1483039-1994-00022 |
| MDR Report Key | 23947 |
| Date Received | 1994-11-20 |
| Date of Report | 1994-11-02 |
| Date of Event | 1994-10-25 |
| Date Facility Aware | 1994-10-26 |
| Report Date | 1994-11-02 |
| Date Reported to FDA | 1994-11-03 |
| Date Reported to Mfgr | 1994-11-03 |
| Date Added to Maude | 1995-08-01 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PARFIN CUTTER/DISPENSER |
| Generic Name | PARAFIN CUTTER/DISPENSER |
| Product Code | IDW |
| Date Received | 1994-11-20 |
| Model Number | NA |
| Catalog Number | PM 901 (P1150-11) |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 24281 |
| Manufacturer | THERMO SEPERATION PRODUCTS |
| Manufacturer Address | 3661 INTERSTATE PARK ROAD N RIVERA BEACH FL 33419 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1994-11-20 |