MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07,08 report with the FDA on 1997-02-24 for CONMED BEND-A-SEAM ABC HANDPIECE 134003 manufactured by Conmed Corp..
[44928]
There was a diathermy burn with the suspect device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1317214-1997-00013 |
| MDR Report Key | 71312 |
| Report Source | 07,08 |
| Date Received | 1997-02-24 |
| Date of Report | 1997-01-28 |
| Report Date | 1997-01-28 |
| Date Mfgr Received | 1997-01-28 |
| Device Manufacturer Date | 1996-04-01 |
| Date Added to Maude | 1997-02-27 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONMED BEND-A-SEAM ABC HANDPIECE |
| Generic Name | ARGON BEAM COAGULATION HANDPIECE |
| Product Code | HQP |
| Date Received | 1997-02-24 |
| Model Number | NA |
| Catalog Number | 134003 |
| Lot Number | J86327A |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | 9 MO |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 71207 |
| Manufacturer | CONMED CORP. |
| Manufacturer Address | 1435-J HENRY BRENNAN DR EL PASO TX 79936 US |
| Baseline Brand Name | CONMED BEND-A-BEAM ABC HANDPIECE |
| Baseline Generic Name | ABC HANDPIECE |
| Baseline Model No | NA |
| Baseline Catalog No | 134003 |
| Baseline ID | * |
| Baseline Device Family | ABC UNITS AND ACCESSORIES |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K961505 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-02-24 |