InjuryIME
LANSINOH THERAPEARL 3 IN 1 BREAST THERAPY
Received Aug 5, 2021 · Event occurred Jul 21, 2021
Report 1519375-2021-00001 · MDR key 12285164
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Product code (IME)
Manufacturer (The Hygenic Corporation)
Model (TP-LNB1)
Device
Product problems
- Overheating of Device
Patient
Not reported
- Burn(s)
- Burn(s)
Narrative
Description of Event or Problem
ON (B)(6) 2021 THE USER STATED THAT SHE HEATED THE THERAPEARL LANSINOH 3 - 1 BREAST THERAPY PACK FOR 13 SECONDS AND ENDED UP BURNING HERSELF ON THE SIDE OF HER BREAST. AN ATTEMPT TO OBTAIN MORE INFORMATION WAS MADE ON (B)(6) 2021 AND AGAIN ON (B)(6) 2021. NO FURTHER DETAILS HAVE BEEN PROVIDED TO DATE.