FDA Adverse Event
Malfunction
Summary report: N
PROLIEVE TEMPERATURE MONITOR
MDR report key: 2153317
·
Received August 21, 2008
Report
- Report Number
- 3005099803-2008-02178
- Event Type
- Malfunction
- Date Received
- August 21, 2008
- Date of Event
- July 17, 2008
- Report Date
- March 17, 2008
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- MEQ
- PMA / PMN Number
- P030006
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WILL NOT BE RETURNED. A DEVICE ANALYSIS CANNOT BE PERFORMED; THEREFORE, THE CAUSE OF THE REPORTED EVENT IS UNDETERMINED. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2008 DURING PREPARATION OF THE PROLIEVE RECTAL TEMPERATURE MONITOR (RTM), IT WAS NOTICED THE DEVICE WAS CRACKED IN THE SHAFT BETWEEN THE HANDLE AND THE TEMPERATURE SENSORS; HOWEVER, THE DEVICE WAS USED AND THE CASE WAS COMPLETED SUCCESSFULLY. NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
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 |