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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLLISTER INCROPORATED PREMIER SOFT CONVEX TAPE BORDERED POUCH

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HOLLISTER INCROPORATED PREMIER SOFT CONVEX TAPE BORDERED POUCH Back to Search Results
Catalog Number 8678
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Skin Inflammation/ Irritation (4545)
Event Date 02/17/2022
Event Type  Injury  
Event Description
It was reported that an end user started developing a skin rash with weepiness under the tape border of his hollister ostomy appliance. He reported that he has had his stoma for 6 years and had been using this appliance the whole time. He reported that this skin rash started 2-3 months ago and has had a skin biopsy, been on oral prednisone, topical hydrocortisone, and received kenalog & consentyx injections to treat this and none of it has worked. He is now calling hollister for suggestions. Hollister will send him samples of products without tape borders for him to try.
 
Manufacturer Narrative
Trend analysis conducted and no adverse trends observed. Device history records reviewed for the lot number provided and found to be complete and accurate. Sample not returned so sample evaluation not possible. Root cause of reported reaction to the tape border of the ostomy appliance cannot be determined.
 
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Brand NamePREMIER SOFT CONVEX TAPE BORDERED POUCH
Type of DevicePREMIER SOFT CONVEX TAPE BORDERED POUCH
Manufacturer (Section D)
HOLLISTER INCROPORATED
2000 hollister drive
libertyville IL 60048 3781
Manufacturer (Section G)
HOLLISTER INCORPORATED
366 draft avenue
stuarts draft VA 24477 9998
Manufacturer Contact
linda wisowaty
2000 hollister drive
libertyville, IL 60048-3781
8476802170
MDR Report Key14490174
MDR Text Key294778466
Report Number1119193-2022-00018
Device Sequence Number1
Product Code EXB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/24/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/24/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number8678
Device Lot Number2C072
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/17/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/24/2022 Patient Sequence Number: 1
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