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POSEY A8070TFRecalls & reported problems

Posey Products, LLC · 8070 SUB-ASSEMBLY · Class 1

Adverse event reports
10
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10190676000996), received between Dec 26, 2024 and Sep 16, 2026 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (7 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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 1 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 4 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 1 reportsJul 2025: 1 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 1 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 1 reportsAug 2026: 0 reportsSep 2026: 1 reportsOct 2026: 0 reports2024202520264
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Mechanical Problem7
  • Insufficient Device Problem Information2
  • Material Puncture/Hole1
  • Non Reproducible Results1

Patient problems

  • No Clinical Signs, Symptoms or Conditions10

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

  • InjurySep 16, 2026Mechanical Problem; Non Reproducible Results

    A PATIENT WAS THRASHING AROUND IN THE POSEY BED AND THE SIDE PANEL POPPED OPEN AT THE ZIPPER. IT ALSO CAUSED A TEAR IN THE SEAM. WHEN SIDE PANEL BECAME UNSECURE THE PATIENT BEGAN TO FALL OUT OF THE BED NO HARM WAS REPORTED TO THE PATIENT. CLINCIANS BELIEVE INCIDENT WAS A DIRECT RESULT OF PATIENT USING EXCESSIVE FORCE INSIDE THE ENCLOSURE BED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50787880 ↗
  • MalfunctionJul 20, 2026Mechanical Problem

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25882938 ↗
  • MalfunctionJan 28, 2026Material Puncture/Hole

    PATIENT ESCAPED CANOPY THROUGH HOLE IN NETTING. NO INJURIES OF PATIENT OR STAFF WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24205555 ↗
  • MalfunctionJul 1, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

    CUSTOMER REPORTED AN INCIDENT WITH THE POSEY BED WHERE A TODDLER WAS FOUND ON THE FLOOR OUTSIDE OF THE BED ENCLOSURE DUE TO AN UNSECURED ZIPPER. THE TODDLER OR ANY STAFF DID NOT SUFFER ANY INJURIES IN THE RELATED EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22378766 ↗
  • MalfunctionJun 23, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

    CUSTOMER STATES THAT THEIR CUSTOMER HAD A PATIENT WHO FELL OUT OF THE ENCLOSED BED. THE PATIENT WAS ABLE TO PENETRATE THE ZIPPER TRACT NEAR AT BOTTOM PART OF PANEL WITH ALL CLIPS/BUCKLES ENGAGED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22310018 ↗
  • MalfunctionMar 17, 2025Mechanical Problem; Mechanical Problem

    8070 S/N (B)(6) HAS ZIPPER DAMAGE, RIGHT SIDE PANEL HAS ZIPPER TEETH SPLIT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21620418 ↗
  • MalfunctionMar 10, 2025Mechanical Problem; Mechanical Problem

    S/N (B)(6) HAS ZIPPER DAMAGE, MATTRESS ENVELOPE ZIPPER IS SPLITTING ON THE TRACT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21566372 ↗
  • MalfunctionMar 10, 2025Mechanical Problem; Mechanical Problem

    SUPPLEMENTAL MEDWATCH SUBMITTED FOR ADDITIONAL INFORMATION RELATED TO A PREVIOUSLY SUBMITTED REPORT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21560474 ↗
  • MalfunctionMar 6, 2025Mechanical Problem; Mechanical Problem

    S/N (B)(6) HAS ZIPPER DAMAGE, ZIPPER SPLIT ON RIGHT SIDE PANEL.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21536619 ↗
  • MalfunctionDec 26, 2024Mechanical Problem; Mechanical Problem

    SN (B)(6) ZIPPER IS BROKEN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21019295 ↗

Other Patient Bed With Canopy/Restraints devices

All Patient Bed With Canopy/Restraints devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.