• 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 FLEXTEND TAPE BORDERED 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 FLEXTEND TAPE BORDERED CUT TO FIT BARRIER Back to Search Results
Catalog Number 14803
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Skin Inflammation/ Irritation (4545)
Event Date 12/18/2020
Event Type  Injury  
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 irritation under the ostomy barrier and tape border cannot be determined.
 
Event Description
It was reported that an end user developed skin irritation under the hollister new image ostomy barrier approximately 1 ½ years ago. She was told it was a yeast infection which became septic and she was hospitalized. She reported that the skin irritation has never gone away fully. She reports now having blisters on the skin and it is very itchy. She states this is under both the barrier and the tape border of the barrier. She reports she was prescribed miconazole which did not work fully so she was recently prescribed betamethasone and clotrimazole ointment. She reports that is helping. She reports having an allergy to adhesives. Hollister customer service is sending her samples of ceraplus barriers for her to try.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameNEW IMAGE FLEXTEND TAPE BORDERED CUT TO FIT BARRIER
Type of DeviceNEW IMAGE FLEXTEND TAPE BORDERED 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 Key14490290
MDR Text Key292580692
Report Number1119193-2022-00019
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 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 Number14803
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received05/16/2022
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: 05/24/2022 Patient Sequence Number: 1
-
-