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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLLISTER INCROPORATED CONFORM 2 FLEXTEND CUT TO FIT OSTOMY BARRIER

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HOLLISTER INCROPORATED CONFORM 2 FLEXTEND CUT TO FIT OSTOMY BARRIER Back to Search Results
Catalog Number 35500
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Skin Inflammation/ Irritation (4545)
Event Date 03/25/2022
Event Type  Injury  
Manufacturer Narrative
Although hollister does not sell sku 35500 in the us, a similar ostomy barrier product, sku 14203, is sold in the us. Trend analysis conducted and no adverse trends observed over the last 3 years. Device history records (dhr) review conducted and was found to be complete and accurate. Sample not returned so sample evaluation not possible. Root cause of the skin reaction to the adhesive cannot be determined.
 
Event Description
It was reported that an ostomate was experiencing a skin reaction to the hollister conform 2 ostomy barrier after 3 days of use. It was reported that they changed the appliance to a convex barrier to see if it improved things, but it did not. It was further reported that the person saw a dermatologist for the skin reaction to the adhesive on the barrier and was prescribed a corticoïde medication. It is reported that the skin reaction has not resolved yet.
 
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Brand NameCONFORM 2 FLEXTEND CUT TO FIT OSTOMY BARRIER
Type of DeviceCONFORM 2 FLEXTEND CUT TO FIT OSTOMY BARRIER
Manufacturer (Section D)
HOLLISTER INCROPORATED
2000 hollister drive
libertyville IL 60048 3781
Manufacturer (Section G)
HOLLISTER LIETUVA UAB
oro parko str. 2, sergeicikai
karmelavos
kauno raj., LT-54 462
LH LT-54462
Manufacturer Contact
linda wisowaty
2000 hollister drive
libertyville, IL 60048-3781
8476802170
MDR Report Key14135099
MDR Text Key289443798
Report Number3016675012-2022-00002
Device Sequence Number1
Product Code EXB
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/18/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number35500
Device Lot Number1J209
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/30/2022
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: 04/18/2022 Patient Sequence Number: 1
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