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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLLISTER INCROPORATED PREMIER FLEXTEND POUCH WITH CTF BARRIER

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HOLLISTER INCROPORATED PREMIER FLEXTEND POUCH WITH CTF BARRIER Back to Search Results
Catalog Number 8631
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Skin Inflammation/ Irritation (4545)
Event Date 07/14/2022
Event Type  Injury  
Manufacturer Narrative
Trend analysis conducted and no adverse trends for skin irritation identified. Device history record (dhr) review conducted and records found to be complete and accurate. Sample not returned so sample evaluation not possible. Root cause of skin irritation and bumps under the ostomy barrier cannot be determined.
 
Event Description
It was reported that an end user went to the doctor last thursday because she was experiencing skin irritation and red bumps under the hollister premier ostomy barrier. She reported that this affected her skin around her peristomal hernia under the barrier. She reported that the doctor said it was a "summer rash" and prescribed her two antibiotic creams that she was to mix together and used on her peristomal skin when she changed her barrier. The end user reported that she gets this rash in the summers and has previously used the creams. She said that this is not a lot-specific problem but rather has to do with her hernia and the weather. She reported that since starting the creams last thursday, the area has almost completely cleared up already.
 
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Brand NamePREMIER FLEXTEND POUCH WITH CTF BARRIER
Type of DevicePREMIER FLEXTEND POUCH WITH CTF BARRIER
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 Key15104472
MDR Text Key296594419
Report Number1119193-2022-00027
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 Non-Healthcare Professional
Type of Report Initial
Report Date 07/26/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/26/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number8631
Device Lot Number2C242
Was Device Available for Evaluation? No
Date Manufacturer Received07/20/2022
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 Unkown

Patient Treatment Data
Date Received: 07/26/2022 Patient Sequence Number: 1
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