MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2003-11-17 for FREEMAN-GORNEY RHYTIDECTOMY SCISSORS, SUR P-6835 * manufactured by Padgett Instruments, Inc..
[16477686]
Bought 2 new padgett super cut scissors for face lift from the sales representative. Although the scissors are new they didn't cut properly. Additional information was received in 2003 that these instruments were in contact with patients although no injuries have been reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1910735-2003-00038 |
| MDR Report Key | 496687 |
| Report Source | 01,08 |
| Date Received | 2003-11-17 |
| Date of Report | 2003-11-17 |
| Date Mfgr Received | 2003-10-16 |
| Date Added to Maude | 2003-11-24 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | JENNA KARABAS |
| Manufacturer Street | 311C ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362236 |
| Manufacturer G1 | PADGETT INSTRUMENTS |
| Manufacturer Street | 1520 GRAND STREET |
| Manufacturer City | KANSAS CITY MO 64108 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 64108 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FREEMAN-GORNEY RHYTIDECTOMY SCISSORS, SUR |
| Generic Name | PADGETT SCISSORS |
| Product Code | HRR |
| Date Received | 2003-11-17 |
| Model Number | P-6835 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 485414 |
| Manufacturer | PADGETT INSTRUMENTS, INC. |
| Manufacturer Address | 1520 GRAND ST. KANSAS CITY MO 641081404 US |
| Baseline Brand Name | FREEMAN-GORNEY RHYTIDECTOMY SUPERCUT SCISSORS |
| Baseline Catalog No | P-6835 |
| Baseline Device Family | PADGETT SCISSORS |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2003-11-17 |