PREMIER SOFTFLEX DRAINABLE OVAL CUT TO FIT ONE PIECE POUCHING SYSTEM
Received Sep 11, 2019 · Event occurred Aug 26, 2019
Report 9616668-2019-00004 · MDR key 8988855
Device
Generic name
Premier Softflex Drainable Oval Cut To Fit One Piece Pouching System
Manufacturer
Hollister IncorporatedCatalog number
88402
Lot number
UNKNOWN
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
67 YR
- Unspecified Infection
- Unspecified Infection
Narrative
Additional Manufacturer Narrative
END USER'S WEIGHT IS NOT KNOWN SO AN ESTIMATE WAS USED. DESPITE NUMEROUS ATTEMPTS, UNABLE TO REACH END USER FOR FURTHER INFORMATION. LOT NUMBER WAS NOT PROVIDED SO DHR REVIEW IS NOT POSSIBLE. SAMPLE NOT PROVIDED SO SAMPLE EXAMINATION NOT POSSIBLE. TREND ANALYSIS CONDUCTED AND NO TREND OBSERVED FOR THIS PRODUCT AND ISSUE. THE ROOT CAUSE OF THE REPORTED SKIN IRRITATION AND INFECTION CANNOT BE DETERMINED.
Description of Event or Problem
AN OSTOMATE REPORTED THAT HER SKIN WAS RAW AND BURNING FROM STOOL GETTING ON HER SKIN UNDER THE OSTOMY APPLIANCE. THE DOCTOR TOLD HER IT WAS AN INFECTION AND GAVE HER ANTIBIOTICS. NO OTHER INFORMATION IS KNOWN.