FDA Adverse Event
Other
Summary report: N
ARBO2 SOFT-E CARE COVERS
MDR report key: 3853776
·
Received May 30, 2014
Report
- Report Number
- 9681860-2014-00007
- Event Type
- Other
- Date Received
- May 30, 2014
- Date of Event
- April 18, 2014
- Report Date
- May 8, 2014
- Manufacturer
- COVIDIEN
- Product Code
- FMT
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
Description of Event or Problem · 1
IT WAS REPORTED TO COVIDIEN ON 05/08/2014 THAT A CUSTOMER HAD AN ISSUE WITH A TEMPERATURE PROBE COVER. THE CUSTOMER REPORTED THAT THE STICKERS ARE COMING OFF AND DO NOT ADHERE WELL AT ALL. THE CUSTOMER CONFIRMED THAT THEY ARE NOT USING ANY OTHER MEANS TO REGULATE THE BABY'S TEMPERATURE, JUST THE SKIN PROBE FOR TEMP AND FOLLOWING THROUGH WITH AXILLARY CHECKS Q30 MIN. THE CUSTOMER ATTEMPTED TO REAPPLY THE PROBE SO THAT THE WARMER ADJUSTED APPROPRIATELY. THE CUSTOMER FURTHER REPORTED THAT THE BABY WAS NOT HARMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 319773 | ARBO2 SOFT-E CARE COVERS | TEMPERATURE PROBE COVER | FMT | COVIDIEN | 31424784 | 408301X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |