MalfunctionFMP
PRIMO
Received Jan 2, 2026 · Event occurred Sep 6, 2023
Report 3004824601-2026-00011 · MDR key 23950999
Device
Product problems
- Inadequate or Insufficient Training
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
ON(B)(6) 2023, CUSTOMER REPORTED THAT BPW04FL-1 WEDGE, 19" FIRM BODY (PURPLE) COMPRESSED FLAT UNDER THE WEIGHT OF THE PATIENT DURING USE. THEY ARE ESTIMATING THAT THIS IS OCCURRING FOR PATIENTS OVER 300 LBS.
Additional Manufacturer Narrative
THESE MEDICAL DEVICE REPORTS (MDRS) ARE BEING FILED PAST THE REGULATORY REPORTING TIMEFRAME AS THEY ARE A RESULT OF A RETROSPECTIVE REVIEW OF OUR COMPLAINTS. NO SERIOUS INJURY REPORTED.