Direct Supply 1070013BEIRecalls & reported problems
Hoffmann NOA Medical Industries, LLC · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00817492011601), received between Jan 29, 2026 and Jan 29, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
Patient problems
- Skin Tears1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 29, 2026Detachment of Device or Device Component
CUSTOMER REPORTED THAT A RESIDENT AT CARE FACILITY HAD A SKIN TEAR THAT NEEDED 37 STITCHES ALLEGEDLY CAUSED BY AN EXPOSED OPENING FOR AN EXPANSION KIT ON A LONG-TERM CARE BED FRAME. CUSTOMER HAS YET TO PROVIDE PATIENT DETAILS. MANUFACTURER SENDING REPLACEMENT PLASTIC END CAPS TO COVER THE OPENING. WE ARE REPORTING WIT THE INFORMATION PROVIDED OUT OF AN ABUNDANCE OF CAUTION.
Patient problems: Skin Tears
MAUDE report 24214929 ↗
Other Bed, Ac-Powered Adjustable Hospital devices
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- InTouch 2141Stryker Corporation · BED, AC-POWERED ADJUSTABLE HOSPITAL2 deaths361 reports
- Citadel Plus FX811B3B4AMABBArjohuntleigh AB · BED, AC-POWERED ADJUSTABLE HOSPITAL2 deaths358 reports
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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