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

MAUDE Adverse Event Report: HOLLISTER INCORPORATED 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 INCORPORATED NEW IMAGE FLEXTEND TAPE BORDERED CUT TO FIT BARRIER Back to Search Results
Catalog Number 14603
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Skin Irritation (2076)
Event Date 07/17/2018
Event Type  Injury  
Manufacturer Narrative
End user's weight not known so estimation used. Trend data reviewed and no adverse trend observed. Biocompatibility testing has been performed in accordance with iso 10993 and materials were found to be non-sensitizers. Dhr review conducted and results found to be complete and accurate. Sample review not possible because no sample available. The root cause of the skin irritation cannot be determined.
 
Event Description
It was reported that an end user has been experiencing skin irritation of his peristomal skin over the past 2 years while using the hollister ostomy barrier. He has been to a dermatologist who diagnosed it as atopic dermatitis and was prescribed methotrexate and doxycycline. This condition resolves and then reappears. He will follow up with his ostomy nurse and hollister is sending other samples of ostomy barriers for him 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 INCORPORATED
2000 hollister drive
libertyville, il
Manufacturer (Section G)
HOLLISTER INCORPORATED
366 draft avenue
stuarts draft, va
Manufacturer Contact
linda wisowaty
2000 hollister drive
libertyville., 
6802170
MDR Report Key10333347
MDR Text Key200636035
Report Number1119193-2020-00017
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 07/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/28/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number14603
Device Lot Number9J122
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/17/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/28/2020 Patient Sequence Number: 1
-
-