FDA Adverse Event
Injury
Summary report: N
VAC II HANDSWITCH NON-STERILE
MDR report key: 826778
·
Received March 9, 2007
Report
- Report Number
- 1717344-2007-00050
- Event Type
- Injury
- Date Received
- March 9, 2007
- Report Date
- February 8, 2007
- Manufacturer
- VALLEYLAB, QA
- Product Code
- GEI
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
AT THE END OF THE TONSILLECTOMY AND ADENOIDECTOMY SURGICAL PROCEDURE, BURN INJURY WAS OBSERVED ON THE RIGHT CORNER OF THE PATIENT'S MOUTH. THE CUSTOMER REPORTS A MALE PATIENT RECEIVED A BURN TO THE RIGHT CORNER OF HIS MOUTH THAT COULD POSSIBLY CAUSE A DEFORMITY DUE TO CONSTRICTION, SCARRING, IRREGULAR HEALING AND SOFT TISSUE DAMAGE. THE PATIENT HAS RECEIVED ONE ADDITIONAL SURGICAL PROCEDURE TO DATE FROM A PLASTIC SURGEON AND WILL MOST LIKELY HAVE 1 OR 2 MORE PROCEDURES WITHIN THE NEXT SEVERAL YEARS. PER THE CUSTOMER, THE PATIENT IS BEING MONITORED ON A MONTHLY BASIS UNDER THE CARE OF A PLASTIC SURGEON.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VAC II HANDSWITCH NON-STERILE | ESU ACCESSORY | GEI | VALLEYLAB, QA | * | 111170 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 2 YR | Required Intervention |