NEW IMAGE CONVEX FLEXTEND 57MM 2-1/4' FLG 29MM 1-1/8' PS
Received Jun 30, 2020 · Event occurred Jun 13, 2020
Report 1119193-2020-00012 · MDR key 10212787
Device
Generic name
New Image Convex Flextend Barrier
Manufacturer
Hollister IncorporatedCatalog number
15905
Lot number
UNKNOWN
Product problems
- Inadequacy of Device Shape and/or Size
- Adverse Event Without Identified Device or Use Problem
- Inadequacy of Device Shape and/or Size
- Adverse Event Without Identified Device or Use Problem
Patient
86 YR
- Abrasion
- Blood Loss
- Abrasion
- Blood Loss
Narrative
Additional Manufacturer Narrative
END USER'S WEIGHT NOT KNOWN SO ESTIMATION USED. TREND DATA REVIEWED AND NO ADVERSE TREND OBSERVED. DHR REVIEW COULD NOT BE CONDUCTED BECAUSE LOT NUMBER IS NOT KNOWN. SAMPLE REVIEW NOT POSSIBLE BECAUSE NO SAMPLE AVAILABLE. THE ROOT CAUSE OF THE STOMA BLEED CANNOT BE DETERMINED HOWEVER THE COMBINATION OF USING A BARRIER WITH AN OPENING TOO SMALL FOR HIS STOMA SIZE COMBINED WITH THE PATIENT BEING ON TWO BLOOD THINNERS LIKELY CONTRIBUTED TO THE STOMA INJURY AND RESULTING BLOOD LOSS.
Description of Event or Problem
IT WAS REPORTED THAT AN END USER EXPERIENCED A STOMA BLEED AFTER BEING PLACED IN A BARRIER WITH A SMALLER STOMA OPENING. HE WAS ADVISED BY HIS STOMA NURSE THAT HE NEEDED TO BE IN A SMALLER BARRIER, WHICH HE USED BUT THEN EXPERIENCED A BLEEDING STOMA. HE WENT TO THE EMERGENCY DEPARTMENT WHERE THEY USED A GEL DRESSING AND GAVE HIM A BLOOD TRANSFUSION. LATER THAT DAY, THE STOMA STARTED BLEEDING AGAIN SO THEY USED SILVER NITRATE CAUTERY. THE BLEEDING HAS SINCE SUBSIDED. HOLLISTER IS PROVIDING HIM BARRIERS WITH A LARGER STOMA OPENING.