Handicare 400032Recalls & reported problems
Handicare USA, Inc. · Large Care Sling w/Head Support - Knit · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00810045512006), received between Mar 22, 2021 and Mar 22, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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.
Most reported problems
Device problems
- Break1
- Material Split, Cut or Torn1
Patient problems
- Fall1
- Laceration(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 22, 2021Break; Material Split, Cut or Torn; Material Split, Cut or Torn
WHILE TRANSFERRING A PATIENT, ONE OF THE BLUE STRAPS BROKE ON THE SLING (RH SHOULDER), CAUSING THE PATIENT TO FALL TO THE FLOOR. PATIENT RECEIVED A LACERATION INJURY TO THE LEFT SIDE OF PATIENT'S FOREHEAD WHEN HE STRUCK THE GROUND. PATIENT RECEIVED X-RAYS AND FOLLOW-UP TREATMENT FOR THE LACERATION AND WILL CONTINUE TO BE MONITORED JUST IN CASE. THE CARE FACILITY STATED THERE WERE TWO CNA'S IN THE ROOM AT THE TIME OF THE INCIDENT AND BOTH WERE PARTICIPATING IN THE TRANSFER. BOTH THE SLING AND THE MACHINE IT WAS USED ON HAVE BEEN REMOVED FROM SERVICE PENDING AN INVESTIGATION BY SAFETY STAFF AT THE HOSPITAL.
Patient problems: Fall; Laceration(s)
MAUDE report 11547787 ↗
Other Sling, Overhead Suspension, Wheelchair devices
- Handicare 341610Handicare USA, Inc. · Sling, Overhead Suspension, Wheelchair3 reports
- Handicare 547810Handicare USA, Inc. · Sling, Overhead Suspension, Wheelchair2 reports
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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