7383 GOMCO DELUXE 1.3 52000033

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2009-02-26 for 7383 GOMCO DELUXE 1.3 52000033 manufactured by Covidien.

Event Text Entries

[1203501] It was reported to covidien in 2009 that a customer had a problem with a gomco. The customer reports upon tightening the 1. 3 gomco, the doctor experienced cutting of the foreskin of the penis without using the blade. The gomco itself cut the foreskin and the infant received a cut that require sutures.
Patient Sequence No: 1, Text Type: D, B5


[8328937] An investigation is currently underway. Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1282497-2009-00009
MDR Report Key1379523
Report Source06
Date Received2009-02-26
Date of Report2009-02-09
Date of Event2009-01-05
Report Date2009-02-09
Date Reported to Mfgr2009-02-09
Date Mfgr Received2009-02-09
Date Added to Maude2009-08-03
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location3
Manufacturer ContactJANICE NEVIUS
Manufacturer Street15 HAMPSHIRE ST.
Manufacturer CityMANSFIELD MA 02048
Manufacturer CountryUS
Manufacturer Postal02048
Manufacturer Phone5082616283
Manufacturer G1COVIDIEN
Manufacturer Street37 BLVD. INSURGENTES LIBRIAMENTO
Manufacturer CityTIJUANA
Manufacturer CountryMX
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name7383 GOMCO DELUXE 1.3
Generic NameGOMCO
Product CodeFHG
Date Received2009-02-26
Model Number52000033
Catalog Number52000033
Lot Number8312169
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeNA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN
Manufacturer Address37 BLVD. INSURGENTES LIBRIAMENTO TIJUANA MX


Patients

Patient NumberTreatmentOutcomeDate
10 2009-02-26

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