PRONE PATIENT POSITIONING KIT
Received Mar 18, 2021 · Event occurred Feb 17, 2021
Report 1034876-2021-00001 · MDR key 11518820
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Skin Inflammation/ Irritation
- Skin Inflammation/ Irritation
Narrative
Additional Manufacturer Narrative
INVESTIGATION FINDING: THE LOT NUMBER REPORTED 1598904 WAS NOT FOUND FOR THIS PRODUCT. QUALITY SPECIALIST WAS UNABLE TO REVIEW MATERIAL INVENTORY. IT WAS DETERMINED THIS WAS A VENDOR ISSUE DUE TO A PROBABLE ISOLATED REACTION FROM THE PATIENT. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS SENT TO CASSEMCO INC. THE SUPPLIER COMPLETED THE SCAR AND ATTACHED SAFETY DATA SHEET AND CERTIFICATE OF ANALYSIS AND COMPLIANCE RESULTS ON PRODUCT. THE CERTIFICATE OF ANALYSIS REPORTED SPECIFICATIONS WITHIN PASSING MEAN VALUES. (B)(4) UNITS OF FINISHED GOOD OF PRODUCT HAVE BEEN SOLD FROM FEBRUARY 2020 TO PRESENT, DURING THAT REVIEW PERIOD THIS IS THE ONLY COMPLAINT RECEIVED FOR THIS PRODUCT. THIS EQUATES TO A COMPLAINT RATIO OF (B)(4). ROOT CAUSE: UNABLE TO DETERMINE THE ROOT CAUSE TO THIS ISSUE DUE TO PROBABLE ISOLATED PATIENT RESPONSE TO FOAM MATERIAL. CORRECTION: NO CORRECTIVE ACTION WAS TAKEN TO THE PRODUCT. PREVENTION AND VERIFICATION: NONE, THIS IS ISOLATED INCIDENT. THE INVESTIGATION IS COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW UP REPORT IF ADDITIONAL INFORMATION BECOMES AVALIABLE.
Additional Manufacturer Narrative
ROOT CAUSE CAN NOT BE DETERMINED AT THIS TIME. THE INVESTIGATION IS INCOMPLETE AT THIS TIME, A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ADDITIONAL INFORMATION ONCE RECEIVED, THIS REPORT WILL BE UPDATED.
Description of Event or Problem
PATIENT WAS PLACED IN THE PRONE POSITION USING M60-360 POSITIONING KIT. NURSE COULD NOT CONFIRM HOW OFTEN THE PATIENT WAS CHECKED FOR PRESSURE INJURY SYMPTOMS OR SKIN IRRITATIONS. PATIENT DID DEVELOP 2 SKIN IRRITATIONS.