MCDOUGAL PROSTATECTOMY CLAMP 242006

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2003-10-17 for MCDOUGAL PROSTATECTOMY CLAMP 242006 manufactured by Rusch, Inc..

Event Text Entries

[19548036] Customer reports jaws not meeting. Not getting a fit clamp.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2429473-2003-00235
MDR Report Key491057
Report Source05
Date Received2003-10-17
Date of Report2003-10-17
Date Mfgr Received2003-10-15
Date Added to Maude2003-10-27
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 FDA3
Event Location0
Manufacturer ContactROLANDA SCOTT, COORDINATOR
Manufacturer Street2450 MEADOWBROOK PARKWAY
Manufacturer CityDULUTH GA 30096
Manufacturer CountryUS
Manufacturer Postal30096
Manufacturer Phone7706230816
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMCDOUGAL PROSTATECTOMY CLAMP
Generic NameUROLOGICAL
Product CodeEXJ
Date Received2003-10-17
Model NumberNA
Catalog Number242006
Lot NumberUNK
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrN
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key479775
ManufacturerRUSCH, INC.
Manufacturer Address2450 MEADOWBROOK PKWY. DULUTH GA 30096 US
Baseline Brand NameMCDOUGAL PROSTATECTOMY CLAMP
Baseline Generic NameUROLOGICAL
Baseline Model NoNA
Baseline Catalog No242006
Baseline IDNA


Patients

Patient NumberTreatmentOutcomeDate
10 2003-10-17

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.