InjuryIME
LANSINOH 3-IN-1 BREAST PACK
Received May 21, 2020 · Event occurred Jun 19, 2017
Report 1519375-2020-00003 · MDR key 10080938
Device
Generic name
Hot/cold Breast Pack
Manufacturer
The Hygenic CorporationProduct problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Burn(s)
- Burn(s)
Narrative
Description of Event or Problem
CUSTOMER ALLEDGED SHE RECEIVED A BURN FROM USING HER LANSINOH 3-IN-1 BREAST PACK.SHE SAID SHE HEATED IT AS INSTRUCTED AND AFTER, IT DID NOT FEEL HOT TO THE TOUCH. AFTER USING HER BREAST PUMP, THE CUSTOMER STATED THAT SHE "HAD A BLACK CHAR BURN" ON HER BREAST.SHE ALSO, STATED A WEEK LATER THAT IT WAS NOT HEALING. THE HYGENIC CORPORATION RECIEVED THIS COMPLAINT FROM THE LANSINOH TEAM ON 4/16/2020. THE CUSTOMER SERVICE TEAM, DID TRY AND OBTAIN MORE INFORMATION, BUT DUE TO LAPSE IN TIME OF OCCURANCE AND NOTIFICATION DATE, NONE WAS RECEIVED.