MalfunctionFMP
MOLNLYCKE STATIC AIR BOOTS
Received Jan 17, 2023 · Event occurred Dec 12, 2022
Report 16183403 · MDR key 16183403
Device
Generic name
Protector, Skin Pressure
Manufacturer
Molnlyck Health CareCatalog number
1400108
Lot number
22140004
Product problems
- Burst Container or Vessel
- Product Quality Problem
- Unintended Deflation
Patient
27375 DA · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
PATIENT PROVIDED A BARIATRIC STATIC AIR CUSHION(MOLNLYCKE WAFFLE CUSHION) AT CLINIC VISIT. HE SENT A MYCHART MESSAGE THE NEXT DAY THAT THE CUSHION HAD BURST AND DEFLATED AND HAD NO WAY TO RE-INFLATE. HE WAS UPSET AT THE QUALITY OF THE PRODUCT THAT HE WAS WITHIN THE WEIGHT RANGE.