• 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 SOFTFLEX COLLECTOR, OSTOMY

  • 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 SOFTFLEX COLLECTOR, OSTOMY Back to Search Results
Model Number 82500
Device Problem Loss of or Failure to Bond (1068)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/22/2019
Event Type  malfunction  
Event Description
Multiple urostomy bags (premier one-piece urostomy pouch-flat extend barrier, tape) found to have adhesive that does not stick.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePREMIER SOFTFLEX
Type of DeviceCOLLECTOR, OSTOMY
Manufacturer (Section D)
HOLLISTER INCORPORATED
2000 hollister dr.
libertyville IL 60048
MDR Report Key8859954
MDR Text Key153245522
Report Number8859954
Device Sequence Number1
Product Code EXB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/16/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/05/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number82500
Device Catalogue Number82500
Device Lot Number242261
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/16/2019
Event Location No Information
Date Report to Manufacturer08/05/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-