Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA PAIN MANAGEMENT UNIVERSAL BLOCK TRAY. ; 44-TRAYS
  • 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
 

INTEGRA PAIN MANAGEMENT UNIVERSAL BLOCK TRAY. ; 44-TRAYS Back to Search Results
Catalog Number 3401013
Device Problems Device Contamination with Chemical or Other Material (2944); Insufficient Information (3190)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Other  
Event Description
Bug inside tray.Discarded.
 
Manufacturer Narrative
The device involved in the reported incident is not available for evaluation.An investigation has been initiated based on the reported info.
 
Manufacturer Narrative
On june 22, 2015, integra investigation completed.Results, failure analysis: the product was not returned and an image of the complaint was not provided.A failure analysis is not possible.Device history evaluation: the device history record was reviewed and the device met all specifications dung the assembly process.Conclusion: a root cause analysis could not be performed.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
UNIVERSAL BLOCK TRAY.
Type of Device
44-TRAYS
Manufacturer (Section D)
INTEGRA PAIN MANAGEMENT
salt lake city UT 84104
Manufacturer Contact
sandra lee
315 enterprise dr
plainsboro, NJ 08536
6099366828
MDR Report Key4877700
MDR Text Key17341001
Report Number1722447-2015-00005
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K960248
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,user facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 06/11/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/26/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number3401013
Device Lot NumberW1504005
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received06/11/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/01/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-