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

MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. STERILIZATION WRAP WRAP, STERILIZATION

  • 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
 

MEDLINE INDUSTRIES, INC. STERILIZATION WRAP WRAP, STERILIZATION Back to Search Results
Lot Number 8581810114
Device Problem Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/31/2018
Event Type  malfunction  
Event Description
Medline sterilization wrap found with holes.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSTERILIZATION WRAP
Type of DeviceWRAP, STERILIZATION
Manufacturer (Section D)
MEDLINE INDUSTRIES, INC.
three lakes drive
northfield IL 60093
MDR Report Key8256291
MDR Text Key133331954
Report Number8256291
Device Sequence Number1
Product Code FRG
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 01/08/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/17/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number8581810114
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/08/2019
Event Location No Information
Date Report to Manufacturer01/17/2019
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?
Type of Device Usage

-
-