PAD 30 MM FOR 1180.16A1, F1
Received Oct 24, 2025 · Event occurred Sep 29, 2025
Report 8010652-2025-0000036 · MDR key 23376738
Device
Generic name
Table And Attachments, Operating-room
Manufacturer
Maquet GmbhModel number
118015A1Catalog number
118015A1
Product problems
- Patient Device Interaction Problem
- Patient Device Interaction Problem
Patient
NA · Unknown
- Localized Skin Lesion
- Localized Skin Lesion
Narrative
Description of Event or Problem
GETINGE BECAME AWARE OF AN EVENT INVOLVING ONE OF OUR ACCESSORIES ¿ 118015A1 - PAD 30 MM FOR 1180.16A1, F1. AS IT WAS STATED, FOLLOWING A 12-HOUR SURGERY, A PRESSURE ULCER WAS DISCOVERED ON THE PATIENT. BASED ON THE INFORMATION PROVIDED, THE EXACT STAGE OF THE PRESSURE ULCER IS CURRENTLY UNKNOWN. WE DECIDED TO REPORT THE ISSUE ACCORDING TO THE CLINICAL EXPERT¿S ASSESSMENT, THAT THE ULCER MAY REPRESENT A SEVERITY CONSIDERED A SERIOUS INJURY.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. THE FULL UNIQUE IDENTIFIER (UDI) # INFORMATION IS NOT AVAILABLE SINCE THE SERIAL NUMBER HAS NOT BEEN RECEIVED.