• 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 MODERMA FLEX SOFT CONVEX CERAPLUS 25 MM PRE-SIZED 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 MODERMA FLEX SOFT CONVEX CERAPLUS 25 MM PRE-SIZED BARRIER Back to Search Results
Catalog Number 59825
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Skin Irritation (2076)
Event Date 07/01/2020
Event Type  Injury  
Manufacturer Narrative
Trend data reviewed and no adverse trends identified. Biocompatibility testing has been performed in accordance with iso 10993 and materials were found to be non-sensitizers. Dhr review completed and no issues identified. Sample review not possible because no sample available. End user's weight not known so estimation used. Product 59825 is not sold in the united states but the similar product, 8414 is sold in the us so this medwatch because of that similar product sold in the us. The root cause of the peristomal skin rash cannot be determined.
 
Event Description
It was reported that an end user developed a bad rash under the hollister ostomy barrier. The end user saw his health care professional and was prescribed oral antibiotics. The rash has since cleared up and he is using a different ostomy barrier product.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMODERMA FLEX SOFT CONVEX CERAPLUS 25 MM PRE-SIZED BARRIER
Type of DeviceMODERMA FLEX SOFT CONVEX CERAPLUS 25 MM PRE-SIZED BARRIER
Manufacturer (Section D)
HOLLISTER INCORPORATED
2000 hollister drive
libertyville, il
Manufacturer (Section G)
HOLLISTER ULC
foxford rd.
rehins
ballina, county mayo
EI
Manufacturer Contact
linda wisowaty
2000 hollister drive
libertyville., 
6802170
MDR Report Key10333345
MDR Text Key207335005
Report Number1119193-2020-00019
Device Sequence Number1
Product Code EXB
Combination Product (y/n)N
Reporter Country CodeEI
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
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 Number59825
Device Lot Number0D223
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/02/2020
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? No
Type of Device Usage Initial

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