MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2003-10-22 for OPTEMP II 8065004603 manufactured by Alcon - Houston.
[19236361]
Pt was having a skin tag removed from right eyelid/temporal region. The sterile field drape ignited when hand held cautery unit was activated. Surgeon removed drape as quickly as posible and applied a cold compress to the site. Pt has been seen in op department again in 2003, and the wound has been redressed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1644019-2003-00029 |
| MDR Report Key | 491618 |
| Report Source | 01,05,07 |
| Date Received | 2003-10-22 |
| Date of Report | 2003-09-23 |
| Date of Event | 2003-09-12 |
| Date Mfgr Received | 2003-09-23 |
| Date Added to Maude | 2003-10-29 |
| 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 | 0 |
| Manufacturer Contact | CHARLES DOLBEE |
| Manufacturer Street | 6201 SOUTH FREEWAY |
| Manufacturer City | FORT WORTH TX 761342099 |
| Manufacturer Country | US |
| Manufacturer Postal | 761342099 |
| Manufacturer Phone | 8175518317 |
| Manufacturer G1 | ALCON-HUSTON |
| Manufacturer Street | 2605 WEST BELLFORT |
| Manufacturer City | HOUSTON TX 77054500 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 77054 5008 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPTEMP II |
| Generic Name | CAUTERY |
| Product Code | HQP |
| Date Received | 2003-10-22 |
| Model Number | OPTEMP II |
| Catalog Number | 8065004603 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 480316 |
| Manufacturer | ALCON - HOUSTON |
| Manufacturer Address | 2650 WEST BELLFORT HOUSTON TX 770545008 US |
| Baseline Brand Name | OPTEMP II |
| Baseline Generic Name | OPTEMP |
| Baseline Model No | OPTEMP II |
| Baseline Catalog No | 8065004603 |
| Baseline ID | NA |
| Baseline Device Family | UNIT, CAUTERY, THERMAL, BATTERY POWERED |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 24 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K820157 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2003-10-22 |