FDA Adverse Event
Malfunction
Summary report: N
LIQUID INFANT HEEL WARMER
MDR report key: 3063713
·
Received April 12, 2013
Report
- Report Number
- 1216677-2013-00011
- Event Type
- Malfunction
- Date Received
- April 12, 2013
- Date of Event
- March 14, 2013
- Report Date
- April 11, 2013
- Manufacturer
- COOPERSURGICAL, INC.
- Product Code
- MPO
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
SAMPLE PRODUCT WAS RETURNED AND THE INVESTIGATION IS UNDERWAY. (B)(4).
Description of Event or Problem · 1
CUSTOMER CALLED FROM (B)(6) HOSPITAL AND STATED THE INFANT HEEL WARMER BURNED A NURSE'S HAND. NUMEROUS FOLLOW-UP CALLS WERE MADE TO ATTAIN ADDITIONAL INFORMATION CONCERNING THE EVENT. THERE WERE ALLEGATIONS THAT THE HEEL WARMER REACHED TEMPERATURES GREATER THAN 104 DEGREES FAHRENHEIT. THE FACILITY TESTED A NUMBER OF DEVICES SUGGESTING AT LEAST A DOZEN EXHIBITED OVERHEATING. THE COMPLAINANT WAS UNABLE TO PROVIDE A LOT NUMBER AT THE TIME. THE ALLEGATION ALSO SUGGESTED THAT THE WARMERS WERE BURNING BABIES FEET. A REQUEST FOR PRODUCT SAMPLES TO BE RETURNED WAS ARRANGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 159663 | LIQUID INFANT HEEL WARMER | NONE | MPO | COOPERSURGICAL, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |