FDA Adverse Event
Other
Summary report: N
89-2220 T & A VALUE SET
MDR report key: 332366
·
Received May 8, 2001
Report
- Report Number
- 1060680-2001-00003
- Event Type
- Other
- Date Received
- May 8, 2001
- Report Date
- April 5, 2001
- Manufacturer
- DEROYAL INC.
- Product Code
- DTL
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
A STAFF PERSON FROM A USER FACILITY REPORTED THAT A SURGEON, WHO WAS PERFORMING AN ACOUSTIC NEUROMA PROCEDURE, MISIDENTIFIED THE MICROWIPE DEVICE CONTAINED IN THIS KIT. ACCORDING TO THE USER FACILITY, THE SURGEON THOUGHT THAT THE MICROWIPE WAS GELFOAM AND PLACED THE DEVICE INTO THE PT. AS SOON AS IT WAS DISCOVERED THAT THE MICROWIPE WAS USED INCORRECTLY, THE SURGERY WAS PROLONGED SO THAT THE SURGEON COULD RETRIEVED THE DEVICE. USER FACILITY STAFF CLAIMS NO FRAGMENTS OF THE DEVICE REMAIN IN THE PT. NO CONSEQUENCES TO PT OCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 21008 | 89-2220 T & A VALUE SET | CBH MANAGED CHOICE BASIN OPTHAMOLO | DTL | DEROYAL INC. | 1 | NOT GIVEN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |