FDA Adverse Event
Malfunction
Summary report: N
PROLIEVE TEMPERATURE MONITOR
MDR report key: 1171418
·
Received September 17, 2008
Report
- Report Number
- 3005099803-2008-04654
- Event Type
- Malfunction
- Date Received
- September 17, 2008
- Date of Event
- August 14, 2008
- Report Date
- August 18, 2008
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- MEQ
- PMA / PMN Number
- P030006
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
THE SERIAL NUMBER PROVIDED BY THE END USER COULD NOT BE CONFIRMED; THEREFORE, THE DEVICE MANUFACTURE DATE AND EXPIRATION DATE CANNOT BE DETERMINED. THE DEVICE HAS NOT BEEN RETURNED; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT.
Description of Event or Problem · 1
ON AUGUST 18, 2008, IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PROLIEVE THERMODILITATION RECTAL TEMPERATURE MONITOR (RTM) WAS USED DURING A BENIGN PROSTATIC HYPERPLASIA (BPH) PROCEDURE IN 2008. ACCORDING TO THE COMPLAINANT, THE RTM READING WAS NOT CORRECT. THE PATIENT CONDITION IS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROLIEVE TEMPERATURE MONITOR | MEQ | BOSTON SCIENTIFIC CORPORATION | M0068808030 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |