RUSCH 244001

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 2001-12-27 for RUSCH 244001 manufactured by Rusch Inc..

Event Text Entries

[211533] The customer reports that the clamps are releasing during vasectomy.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2429473-2001-00241
MDR Report Key369263
Report Source06
Date Received2001-12-27
Date of Report2001-12-26
Date Mfgr Received2001-12-20
Date Added to Maude2002-01-04
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 ContactDONNA MCLEOD, ADMINISTRATOR
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 NameRUSCH
Generic NameNO SCALPEL RING CLAMP
Product CodeKOA
Date Received2001-12-27
Model NumberNA
Catalog Number244001
Lot NumberUNK
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key358377
ManufacturerRUSCH INC.
Manufacturer Address2450 MEADOWBROOK PARKWAY 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 2001-12-27

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