Seat plate extension 116055DCRecalls & reported problems
MAQUET GmbH · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04046768138377), received between Feb 6, 2024 and Feb 6, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (2 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Patient Device Interaction Problem2
- Use of Device Problem2
Patient problems
- Hematoma2
- Ulcer2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryFeb 6, 2024Use of Device Problem; Patient Device Interaction Problem; Use of Device Problem; Patient Device Interaction Problem
ON 31ST JANUARY 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR ACCESSORIES ¿ 116055DC - SEAT PLATE EXTENSION, IPC, EU, WASHABLE USED WITH 720001B2 - MEERA EU WITH AUTO DRIVE. AS IT WAS STATED AND CONFIRMED WITH THE PHOTOGRAPHIC EVIDENCE, POSITIONING OF THE PATIENT OVER THE EDGE RESULTED IN PRESSURE ULCER WITH BLISTER FORMATION. WE DECIDED TO REPORT THE ISSUE DUE TO THE DESCRIBED OUTCOME OF THE EVENT, WHICH CONSTITUTES A SERIOUS INJURY. REF- (B)(4).
Patient problems: Hematoma; Ulcer
MAUDE report 18649859 ↗InjuryFeb 6, 2024Use of Device Problem; Patient Device Interaction Problem; Use of Device Problem; Patient Device Interaction Problem
ON 31ST JANUARY 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR ACCESSORIES ¿ 116055DC - SEAT PLATE EXTENSION, IPC, EU, WASHABLE USED WITH 720001B2 - MEERA EU WITH AUTO DRIVE. AS IT WAS STATED AND CONFIRMED WITH THE PHOTOGRAPHIC EVIDENCE, POSITIONING OF THE PATIENT OVER THE EDGE RESULTED IN PRESSURE ULCER WITH BLISTER FORMATION. WE DECIDED TO REPORT THE ISSUE DUE TO THE DESCRIBED OUTCOME OF THE EVENT, WHICH CONSTITUTES A SERIOUS INJURY.
Patient problems: Hematoma; Ulcer
MAUDE report 18649331 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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