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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NULL SINGLE SHOT EPIDURAL TRAYS

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NULL SINGLE SHOT EPIDURAL TRAYS Back to Search Results
Catalog Number 4947-18
Device Problem Difficult to Insert (1316)
Patient Problems Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
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Brand NameSINGLE SHOT EPIDURAL TRAYS
Manufacturer (Section G)
NULL
MDR Report Key15326424
Report Number3012307300-2022-16901
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/31/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/31/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/01/2022
Device Catalogue Number4947-18
Device Lot Number4167658
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received04/11/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/15/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No

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