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Adverse Event Report

OB SPECIALTIES, INC. MITYVAC II EXTRACTOR DELIVERY KIT   back to search results
Model Number MITYVAC II
Event Date 05/15/1997
Patient Outcome  Life Threatening;
Event Description

Normal vaginal birth; birth; well baby. Device applied 2x for short periods during labor. Immediately after birth infant had low apgar (1 @ 1 minute); improved to 8 @ 5 minutes. Approx 30 minutes after birth infants head increased in size due to bleeding between skull and external tissues. Infant stabilized and transported to tertiary facility.

 
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Brand NameMITYVAC II
Type of DeviceEXTRACTOR DELIVERY KIT
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section D)
OB SPECIALTIES, INC.
1799 northwood crt.
oakland CA 95611
Device Event Key104849
MDR Report Key106665
Event Key100263
Report Number106665
Device Sequence Number1
Product CodeHDB
Report Source User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 06/17/1997
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/18/1997
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL NumberMITYVAC II
Device Catalogue Number007-M
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/05/1997
Event Location Hospital
Date Report TO Manufacturer06/17/1997
Is the Device an Implant? No
Is this an Explanted Device?

Database last updated on February 28, 2009

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