HOLLISTER 9212

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-01-30 for HOLLISTER 9212 manufactured by Hollister, Inc.

Event Text Entries

[5495959] Circumcision performed with plastibell on (b)(6) 2015. Baby unable to void following procedure. Required suprapubic tap and transfer to a pediatric hospital for care under pediatric urologist. Baby required surgically placed bladder drain.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5040608
MDR Report Key4491683
Date Received2015-01-30
Date of Report2015-01-27
Date of Event2015-01-17
Date Added to Maude2015-02-09
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
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 Received2015-01-30
Catalog Number9212
ID NumberITEM #737 SM 1.2 CM
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Sequence No1
Device Event Key0
ManufacturerHOLLISTER, INC


Patients

Patient NumberTreatmentOutcomeDate
101. Life Threatening; 2. Required No Informationntervention 2015-01-30

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