NO SCALPEL VASECTOMY RING CLAMP 244001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2003-07-09 for NO SCALPEL VASECTOMY RING CLAMP 244001 manufactured by Rusch, Inc..

Event Text Entries

[326261] Customer reports rings are too wide.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2429473-2003-00078
MDR Report Key471814
Report Source04
Date Received2003-07-09
Date of Report2003-07-07
Date Mfgr Received2003-06-26
Date Added to Maude2003-07-17
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 PKWY
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 NameNO SCALPEL VASECTOMY RING CLAMP
Generic NameUROLOGICAL
Product CodeKOA
Date Received2003-07-09
Model NumberNA
Catalog Number244001
Lot NumberUNK
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrN
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key460663
ManufacturerRUSCH, INC.
Manufacturer Address2450 MEADOWBROOK PKWY. DULUTH GA 30096 US
Baseline Brand NameVASECTOMY SCALPEL
Baseline Generic NameVASECTOMY INSTRUMENT
Baseline Model NoNA
Baseline Catalog No244001
Baseline IDNA
Baseline Device FamilyANESTHESIA
Baseline Shelf Life [Months]NA
Baseline PMA FlagN
Baseline 510K PMNY
Premarket NotificationK922971
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
10 2003-07-09

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