• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLLISTER INCROPORATED NEW IMAGE SOFT CONVEX CERAPLUS CUT TO FIT BARRIER

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

HOLLISTER INCROPORATED NEW IMAGE SOFT CONVEX CERAPLUS CUT TO FIT BARRIER Back to Search Results
Catalog Number 11703
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Itching Sensation (1943); Urticaria (2278); Skin Inflammation/ Irritation (4545)
Event Date 04/20/2021
Event Type  Injury  
Event Description
It was reported that an end user started developing irritation under the tape border of her hollister ostomy barrier over a year ago. She described the irritation as red, scaly, sometimes open areas and itching. She saw her doctor at that time who prescribed clobetasol propionate topical preparation to apply to her skin under the tape at each appliance change. She reports that she has been using it regularly since. Now, she reports that she experiences this skin irritation under the tape border about 50% of the time. Hollister customer service is sending her other products to trial.
 
Manufacturer Narrative
Trend analysis conducted and no adverse trends observed. Lot number not provided so device history records could not be reviewed. Sample not returned so sample evaluation not possible. Root cause of reported skin irritation under the tape border of barrier cannot be determined.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameNEW IMAGE SOFT CONVEX CERAPLUS CUT TO FIT BARRIER
Type of DeviceNEW IMAGE SOFT CONVEX CERAPLUS CUT TO FIT 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 Key14209761
MDR Text Key290094885
Report Number1119193-2022-00012
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
Type of Report Initial
Report Date 04/26/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number11703
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received04/20/2022
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: 04/26/2022 Patient Sequence Number: 1
-
-