• 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 GEMCORNER STERILIZATION WRAP CONTAINERS, TRAYS, CASSETTES & OTHER ACCESSORIES

  • 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 GEMCORNER STERILIZATION WRAP CONTAINERS, TRAYS, CASSETTES & OTHER ACCESSORIES Back to Search Results
Catalog Number GEMCORNER
Device Problem Physical Property Issue (3008)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/24/2016
Event Type  malfunction  
Event Description
Upon opening case of protective foam corners, a large amount of flaky white debris noted. Unknown white debris was being occasionally found, post-sterilization, under trays inside sterile wrap in operating room. The surgical trays need to be removed from the room, and reprocessed when such unknown debris is found. This white flaky substance looks very similar. Staff has seen similar debris on the gemcorners once in a while, but this particular box had an excessive amount immediately upon opening the case.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameGEMCORNER
Type of DeviceSTERILIZATION WRAP CONTAINERS, TRAYS, CASSETTES & OTHER ACCESSORIES
Manufacturer (Section D)
MEDLINE INDUSTRIES INC
one medline pl
mundelein IL 60060
MDR Report Key5670967
MDR Text Key45724459
Report Number5670967
Device Sequence Number1
Product Code FRG
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 03/02/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/23/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberGEMCORNER
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/02/2016
Device Age1 DY
Event Location Other
Date Report to Manufacturer03/02/2016
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

-
-