InjuryIRT
31-HP800-0, 12" X 24" HEATING PAD, THREE SETTING
Received Apr 15, 2025 · Event occurred Feb 7, 2025
Report MW5169026 · MDR key 21840235
Device
Product problems
- Insufficient Heating
Patient
NA · Unknown
- Cramp(s) /Muscle Spasm(s)
- Cramp(s) /Muscle Spasm(s)
Narrative
Description of Event or Problem
A PERITONEAL DIALYSIS (PD) PATIENT CONTACTED FRESENIUS CUSTOMER SERVICE TO REPORT THAT THE 31-HP800-0, HEATING PAD NO LONGER WORKS, IT IS NOT HEATING THE SOLUTION ENOUGH. THE PATIENT IS NOT SURE WHAT EXACTLY HAPPENED TO IT. THE PATIENT EXPERIENCED CRAMPING DUE TO USING THE SOLUTION COLD, BUT DID NOT HAVE TO GO TO THE HOSPITAL. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).