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Adverse Event Report

CLINICAL INNOVATIONS, INC. KIWI VACUME SILASTIC DELIVERY DEVICE   back to search results
Model Number VAC-6000M
Patient Outcome  Required Intervention;
Event Description

Kiwi silastic applied with mother's consent; after nine pulls with kiwi with mother pushing, child delivered. 5. 5cm laceration noted on baby's head.

 
Event Description

Add'l info rec'd from mfr 12/22/00: no failure analysis was possible on the device since it was not returned. It appears that the device functioned properly. The abrasion was reportedly "superficial" and required no suturing to repair. In mfr's opinion, the reported nine traction pulls appear to be excessive use of the device.

 
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Brand NameKIWI VACUME
Type of DeviceSILASTIC DELIVERY DEVICE
Baseline Brand NameKIWI PALMPUMP
Baseline Generic NameVACUUM DELIVERY SYSTEM
Baseline Model NumberVAC-6000M
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section D)
CLINICAL INNOVATIONS, INC.
6477 s cottonwodd st
murray UT 84107
Device Event Key295086
MDR Report Key304919
Event Key286524
Report NumberMW1020401
Device Sequence Number1
Product CodeHDB
Report Source Voluntary
Report Date 11/14/2000
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/14/2000
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date01/01/2002
Device MODEL NumberVAC-6000M
Device LOT Number000212
Was Device Available For Evaluation? Yes
Is the Device an Implant? No
Is this an Explanted Device? No Answer Provided

Database last updated on December 31, 2008

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