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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA PAIN MANAGEMENT SINGLE SHOT EPIDURAL TRAY; 44TRAYS
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INTEGRA PAIN MANAGEMENT SINGLE SHOT EPIDURAL TRAY; 44TRAYS Back to Search Results
Catalog Number 3404937
Device Problems Tear, Rip or Hole in Device Packaging (2385); Torn Material (3024)
Patient Problems No Known Impact Or Consequence To Patient (2692); Not Applicable (3189)
Event Type  malfunction  
Event Description
Torn wrap tray.Packing discarded.
 
Manufacturer Narrative
The device involved i the reported incident is not available for evaluation.An investigation has been initiated based on the reported info.
 
Manufacturer Narrative
On 07/06/2015 integra investigation completed.Manufacture date unk.Method: failure analysis, device history evaluation.Results: failure analysis - a failure analysis could not be performed because the product was not returned.The device history record could not be reviewed because a lot number was not provided and the product was discarded.Conclusion: a root cause analysis could not be performed.
 
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Brand Name
SINGLE SHOT EPIDURAL TRAY
Type of Device
44TRAYS
Manufacturer (Section D)
INTEGRA PAIN MANAGEMENT
salt lake city UT 84104
Manufacturer Contact
sandra lee
315 enterprise drive
plainsboro, NJ 08536
6099366828
MDR Report Key4875611
MDR Text Key18787066
Report Number1722447-2015-00006
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K945484
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 Number3404937
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/06/2015
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 Sequence Number1
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