• 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 PREMIER FLEXTEND BARRIER WITH TAPE AND LOCK N ROLL CLOSURE OSTOMY POUCHING SYSTEM

  • 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 PREMIER FLEXTEND BARRIER WITH TAPE AND LOCK N ROLL CLOSURE OSTOMY POUCHING SYSTEM Back to Search Results
Model Number 8331
Device Problem Insufficient Information (3190)
Patient Problem Tissue Breakdown (2681)
Event Date 01/01/2018
Event Type  Injury  
Manufacturer Narrative
There was no evidence of a device malfunction. There is no trend observed for this sku and complaint type.
 
Event Description
It was reported that the end user developed irritation on (b)(6) 2018. The area is red, irritated and bleeds easily. On (b)(6) 2018 she sought medical treatment and was prescribed oral antibiotics and clotrimazole and bethamethazone ditropionate. She is beginning to see a little improvement.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePREMIER FLEXTEND BARRIER WITH TAPE AND LOCK N ROLL CLOSURE
Type of DeviceOSTOMY POUCHING SYSTEM
Manufacturer (Section D)
HOLLISTER INCORPORATED
2000 hollister drive
libertyville IL 60068
Manufacturer (Section G)
HOLLISTER INCORPORATED
366 draft avenue
stuarts draft VA 24477 9998
Manufacturer Contact
anne riba
2000 hollister dr
libertyville, IL 60048
8476805625
MDR Report Key7413228
MDR Text Key104913550
Report Number1119193-2018-00014
Device Sequence Number1
Product Code EXB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Patient
Type of Report Initial
Report Date 03/16/2018,04/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/10/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number8331
Device Catalogue Number8331
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location Home
Date Report to Manufacturer03/16/2018
Date Manufacturer Received03/16/2018
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 Initial

Patient Treatment Data
Date Received: 04/10/2018 Patient Sequence Number: 1
-
-