MalfunctionFOH
TEMPERATURE THERAPY PAD
Received Jun 14, 2011 · Event occurred May 19, 2011
Report 1313850-2011-00139 · MDR key 2135224
Device
Generic name
Temperature Therapy Pad
Manufacturer
Stryker Corp Dba GaymarModel number
TP22GCatalog number
NA
Lot number
NA
Product problems
- Partial Blockage
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PAD APPEARED TO HAVE A BLOCKAGE AND IT WOULD NOT ALLOW WATER TO FLOW THROUGH THE ENTIRE PAD. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES WERE REPORTED. CUSTOMER STATED THAT THE PAD APPEARED TO HAVE A BLOCKAGE IN. IT WOULDN'T LET WATER FLOW THROUGH THE WHOLE PAD.
Additional Manufacturer Narrative
RESULT: INTERNAL BUTTON WELDS HAVE PEELED, CAUSING THE MATERIAL TO STRETCH AND FORM HOLES. CONCLUSION: CUSTOMER REQUESTED CREDIT FOR PAD.