FDA Adverse Event Injury Summary report: N

KAZ INC

MDR report key: 138341 · Received December 5, 1997

Report

Report Number
1314800-1997-90011
Event Type
Injury
Date Received
December 5, 1997
Date of Event
December 1, 1997
Report Date
December 4, 1997
Manufacturer
KAZ INC.
Product Code
IRT
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
MD, US
Reporter Occupation
NOT APPLICABLE

Narratives

Description of Event or Problem · 1

CONSUMER FELL ASLEEP WITH PAD ON HER LEG, CONTRARY TO TO CO'S INSTRUCTION. WHEN SHE AWOKE, APPROX 1/2 HR LATER, SHE NOTICED A BURN ON HER LEG. PT WENT TO THE DR TO HAVE THE BLISTER DRAINED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 KAZ INC HEATING PAD IRT KAZ INC. HP710 NA

Patients

Seq Age Sex Outcome Treatment
1 NA Required Intervention