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U.S. Department of Health and Human Services

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

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HOLLISTER INCROPORATED CONFORM 2 FLEXTEND SOFT CONVEX CUT TO FIT OSTOMY BARRIER Back to Search Results
Catalog Number 15A00
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erythema (1840); Itching Sensation (1943); Skin Inflammation/ Irritation (4545)
Event Date 05/23/2022
Event Type  Injury  
Manufacturer Narrative
Although hollister does not sell (b)(4) in the us, a similar ostomy barrier product, (b)(4), is sold in the us. Trend analysis conducted and no adverse trends observed over the last 3 years. Device history records (dhr) could not be reviewed because lot number was not provided. Sample not returned so sample evaluation not possible. Root cause of the skin reaction to the hollister ostomy product cannot be determined.
 
Event Description
It was reported that about one week after radiation therapy, an end user started to experience itching at the stoma under the hollister conform 2 ostomy barrier. It was reported that the itching lead to skin redness and oozing which spread to other areas of his body including skin ridges & folds and the eyes. It was reported that the end user went to a dermatologist who conducted allergy testing which showed he reacted to hollister products. It was further reported that he was prescribed a milky tincture to treat the areas. It was reported that the affected areas have now scabbed over. It was reported that according to the doctors at the dermatology clinic, it's due to an allergic reaction that blossomed after his immune system rebooted after radiation therapy.
 
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Brand NameCONFORM 2 FLEXTEND SOFT CONVEX CUT TO FIT OSTOMY BARRIER
Type of DeviceCONFORM 2 FLEXTEND SOFT CONVEX 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 Key14547229
MDR Text Key292968019
Report Number3016675012-2022-00003
Device Sequence Number1
Product Code EXB
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 05/31/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/31/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number15A00
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/23/2022
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: 05/31/2022 Patient Sequence Number: 1
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