FDA.reportPublic FDA data

MAUDE MDR 9853763

MDR report key
9853763
Report number
1219103-2020-00268
Event key
0
Event type
3
Date received
2020-03-19
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
JILL SARAIVA
Address
15 HAMPSHIRE STREET MANSFIELD MA 02048 US
Phone
508-508-5086
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1"WARMERS, INFANT HEEL W/TABS"INFANT HEEL WARMER (CHEMICAL HEAT PACK)COVIDIENMPOMH00002TMH00002T* Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-190

Event Narratives#

N

Patient 1

THE INCIDENT SAMPLE HAS BEEN REQUESTED BUT TO DATE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED, OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED.

D

Patient 1

THE CUSTOMER REPORTED THAT THE INFANT HEEL WARMER PACK EXPLODED WHEN SQUEEZED FOR ACTIVATION. NO PATIENT OR CLINICIAN HARM AT THIS TIME. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER ON (B)(6) 2020 STATING THAT THE ACTIVATED GEL SHOT OUT ALL OVER THE CARE PROVIDER AND SURROUNDING SPACE. THE ISSUE OCCURRED PRIOR TO PLACING THE HEEL WARMER ON THE INFANT.