PROTECTOR, SKIN PRESSURE
Received Jun 13, 2022 · Event occurred May 4, 2022
Report 14674221 · MDR key 14674221
Device
Generic name
Protector, Skin Pressure
Manufacturer
Molnlycke Health CareCatalog number
1400106
Lot number
22030003
Product problems
- Deflation Problem
Patient
31025 DA · Male
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
WAFFLE CUSHION DEFLATED WHILE PATIENT WAS USING CUSHION IN CHAIR. THE CHAIR CUSHION IS UTILIZED FOR PRESSURE REDUCTION FOR SKIN CARE. IF THIS PRODUCT IS DEFLATED, IT INCREASED THE RISK FOR HOSPITAL ACQUIRED PRESSURE INJURIES. THUS, IT HAS THE POTENTIAL FOR SKIN INTEGRITY IMPAIRMENT. MANUFACTURER RESPONSE FOR PRESSURE REDUCTION CUSHION, (BRAND NOT PROVIDED) (PER SITE REPORTER). EQUIPMENT FAILURE REPORTED TO MANUFACTURER'S PRODUCT SAFETY SPECIALIST. EQUIPMENT IS AVAILABLE FOR RETURN. COMMUNICATION RECEIVED FROM PRODUCT SAFETY SPECIALIST INDICATING SAMPLE IS NOT NEEDED FOR RETURN. SAMPLE DISCARDED.