FDA Adverse Event
Other
Summary report: N
CT/MR FLETCHER TANDEM AND OVOID SET
MDR report key: 1816227
·
Received August 13, 2010
Report
- Report Number
- 9611894-2010-00004
- Event Type
- Other
- Date Received
- August 13, 2010
- Date of Event
- July 8, 2010
- Report Date
- August 11, 2010
- Manufacturer
- NUCLETRON BV
- Product Code
- JAQ
- PMA / PMN Number
- K091154
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
ON (B)(6) 2010, THE CUSTOMER SITE USED THE CT/MR FLETCHER TANDEM AND OVOID SET (B)(4) TO TREAT A PT. THE PROCEDURE WENT WELL, AND THE PT WENT HOME. NEXT DAY, UPON PT EXAMINATION, THE DOCTOR DISCOVERED THAT THE CERVICAL STOPPER PIECE (B)(4) WAS LEFT BEHIND INSIDE THE PT. ON (B)(6) 2010, THE HOSPITAL ADMINISTRATOR CALLED NUCLETRON'S ONCO SUPPORT LINE TO TELL US OF THE PROBLEM. THIS PT IS WELL AND DID NOT SUFFER ANY DISCOMFORT OR DAMAGE DUE TO THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CT/MR FLETCHER TANDEM AND OVOID SET | GYN CT/MR APPLICATOR | JAQ | NUCLETRON BV | 189730-03 | 025766 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |