OBSTIHOOK * OBS-100

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-06-07 for OBSTIHOOK * OBS-100 manufactured by Innovative Medical Products, Llc.

Event Text Entries

[646687] At delivery baby was noted to have three scratch marks on the right cheek. Mother had artificial rupture of membranes by her ob with the obstihook amniotic membrane perforator prior to delivery. No internal monitors were used. Delivery was easy. Cause of scratch marks is unknown.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number876853
MDR Report Key876853
Date Received2007-06-07
Date of Report2007-06-07
Date of Event2007-04-27
Report Date2007-06-07
Date Reported to FDA2007-06-07
Date Added to Maude2007-07-11
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameOBSTIHOOK
Generic NameAMNIOTIC MEMBRANE PERFORATOR
Product CodeHGE
Date Received2007-06-07
Model Number*
Catalog NumberOBS-100
Lot Number1033
ID Number*
OperatorPHYSICIAN
Device AvailabilityN
Device Age1 DY
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key856184
ManufacturerINNOVATIVE MEDICAL PRODUCTS, LLC
Manufacturer Address2515 THREE MILE RD. NW GRAND RAPIDS MI 495341313 US


Patients

Patient NumberTreatmentOutcomeDate
10 2007-06-07

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