HOLLISTER 9234

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-06-11 for HOLLISTER 9234 manufactured by Briggs.

Event Text Entries

[1400695] Baby had a plastibell 1. 4 circumcision performed on (b) (6) 2010 by dr (b) (6) ob/gyn. Dr (b) (6), attending family physician saw pt in the office as f/u routine visit and found the ring was below the glans. The glans had a blueish hue. Baby was sent to a hosp to see a urologist for ring removal - a ring cutter was used to remove device.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5016362
MDR Report Key1726772
Date Received2010-06-11
Date of Report2010-06-11
Date of Event2010-01-24
Date Added to Maude2010-06-21
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameHOLLISTER
Generic NamePLASTIBELL CIRCUMCISION DEVICE
Product CodeFHG
Date Received2010-06-11
Model Number9234
Catalog Number9234
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Sequence No1
Device Event Key0
ManufacturerBRIGGS
Manufacturer Address1931 NORMAN DR S. WAUKEGAN IL 60085671 US 60085 6715


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2010-06-11

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