RUSCH E3320

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,08 report with the FDA on 2002-05-15 for RUSCH E3320 manufactured by Rusch, Inc..

Event Text Entries

[269018] The customer reports that the gastroenterology tubes are coming completely out of the patient.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2429473-2002-00061
MDR Report Key402510
Report Source06,08
Date Received2002-05-15
Date of Report2002-05-07
Date Mfgr Received2002-03-21
Date Added to Maude2002-07-03
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 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 NameTRIPLEPORT GASTROSTOMY CATHETER-20FR
Product CodeKDH
Date Received2002-05-15
Model NumberNA
Catalog NumberE3320
Lot Number108246, 106510, 112142, 108244
ID NumberNA
OperatorLAY USER/PATIENT
Device AvailabilityY
Device Eval'ed by MfgrY
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key391519
ManufacturerRUSCH, INC.
Manufacturer Address2450 MEADOWBROOK PKWY. DULUTH GA 30096 US
Baseline Brand NameTRIPLE-PORT GASTROSTOMY CATHETERS
Baseline Generic NameGASTROSTOMY CATHETER
Baseline Model NoNA
Baseline Catalog NoE3320
Baseline IDNA
Baseline Device FamilyGASTROSTOMY CATHETER
Baseline Shelf Life [Months]NA
Baseline PMA FlagN
Baseline 510K PMNY
Premarket NotificationK891371
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
10 2002-05-15

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