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U.S. Department of Health and Human Services

MAUDE Adverse Event Report:

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Device Problems Material Disintegration (1177); Material Fragmentation (1261); Material Separation (1562)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/09/2020
Event Type  Injury  
Event Description
It was reported that during the removal of placental membranes, attempting spinal anesthetic procedure was difficult. Once the procedure was completed it was noted that one of the spinal needles were incomplete. The spinal anesthetic was successful, and removal of the placental membranes was completed. Lumbar x-ray ap and lateral views was taken, which show the spinal needle near the superior articular facet and not in the spinal canal. The patient was schedule to be transfer. Neuro fellow thinks that she does not need any neuro observations and patient can mobilize without any particular restrictions. No adverse patient effects were reported.
 
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MDR Report Key11255601
MDR Text Key229566437
Report Number3012307300-2021-00727
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Type of Report Initial
Report Date 01/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/30/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 01/30/2021 Patient Sequence Number: 1
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