FDA Adverse Event
Injury
Summary report: N
REFSTAR WITH QWIKPATCH
MDR report key: 935542
·
Received October 26, 2007
Report
- Report Number
- 9673241-2007-00205
- Event Type
- Injury
- Date Received
- October 26, 2007
- Date of Event
- September 27, 2007
- Report Date
- September 27, 2007
- Manufacturer
- BIOSENSE WEBSTER, INC. (JUAREZ)
- Product Code
- DRF
- PMA / PMN Number
- K982415
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- NO INFORMATION
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL PMA/510(K) K980961.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT STARTED TO COMPLAIN ABOUT A BURNING FEELING ON THE BACK AND A RASH WAS DISCOVERED. AFTER A FEW MINUTES, THE PATIENT HAD DIFFICULTIES IN BREATHING WITH HYPOTENSION. CHRONIC OBSTRUCTION PULMONARY DISEASE WAS DISCOVERED DURING PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REFSTAR WITH QWIKPATCH | CATHETER, ELECTRODE RECORDING | DRF | BIOSENSE WEBSTER, INC. (JUAREZ) | D-1210-01 | 13236041 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI YR | Life Threatening |