BLANKET WARMING CABINET
Received Nov 2, 2021 · Event occurred Aug 30, 2021
Report 8010652-2021-00031 · MDR key 12735755
Device
Product problems
- Defective Device
Patient
Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
GETINGE MAQUET (B)(4) IS NOT THE LEGAL MANUFACTURER OF THIS PRODUCT. WE HAVE INFORMED "ENTHERMICS MEDICAL SYSTEMS" WHICH IS THE LEGAL MANUFACTURER OF THIS DEVICE AND FORWARDED THE FACILITY MEDWATCH TO THE LEGAL MANUFACTURER. FEEL TO CONTACT US VIA THE FOLLOWING MAIL ADDRESS SHOULD YOU HAVE ANY QUESTIONS OR NEED FURTHER INFORMATION: (B)(4).
Description of Event or Problem
WE HAVE RECEIVED A FACILITY MEDWATCH REPORT WITH THE UF/IMPORTER REPORT # (B)(4). IN THIS REPORT THE BLANKET WARMING CABINET GET2060 WAS CLAIMED AS DEFECTIVE PRODUCT. IT WAS STATED THAT GEETING SOURCING, LLC IN (B)(4) WAS THE LEGALS MANUFACTURER OF THIS PRODUCT. THIS IS NOT TRUE. ENTHERMICS MEDICAL SYSTEMS IS THE LEGAL MANUFACTURER OF THIS DEVICE. WE HAVE FORWARDED THE FACILITY MEDWATCH TO ENDTHERMICS MEDICAL SYSTEMS. THIS CASE WAS REGISTERED IN OUR COMPLAINT MANAGEMENT SYSTEM WITH REFERENCE # (B)(4). WE HAVE FORWARDED THE FACILITY MEDWATCH REPORT TO THE LEGAL MANUFACTURER.