FDA Adverse Event
Other
Summary report: N
MONOPOLAR FORCEPS, POTTSMITH
MDR report key: 809568
·
Received January 23, 2007
Report
- Report Number
- 1530493-2007-00003
- Event Type
- Other
- Date Received
- January 23, 2007
- Date of Event
- July 21, 2005
- Report Date
- January 22, 2007
- Manufacturer
- OLSEN MEDICAL
- Product Code
- GEI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THIS INCIDENT WAS REPORTED TO HOSPITAL AS INDICATED. IT WAS VERBALLY REPORTED THAT THIS DEVICE WAS BEING USED DURING A BREAST AUGMENTATION. IT IS VERY QUESTIONABLE HOW MULTIPLE SMALL BURNS OCCURRED ON THE LEGS FOR THIS TYPE OF SURGERY. IT IS NOTED IN THE REPORT WE RECEIVED FROM OUR CUSTOMER THAT THIS WAS PROBABLY USER ERROR. NO INTERVENTION WAS REQUIRED.
Description of Event or Problem · 1
THIS REPORT CAME IN FROM ANOTHER COUNTRY. THE PROBLEM REPORTED WAS THAT THE PATIENT SUSTAINED MULTIPLE SMALL BURNS ON THE LEGS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MONOPOLAR FORCEPS, POTTSMITH | MONOPOLAR FORCEPS | GEI | OLSEN MEDICAL | E88-5240 | 113423 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Other |