RUSCH 580214

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 2001-09-07 for RUSCH 580214 manufactured by Rusch Manufacturing Uk Ltd, Rusch Lurgan.

Event Text Entries

[217678] The customer reports that the rectal balloon came off in the patient.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2429473-2001-00161
MDR Report Key351171
Report Source06
Date Received2001-09-07
Date of Report2001-09-05
Date Mfgr Received2001-08-31
Date Added to Maude2001-09-14
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 NameRECTAL BALLOON
Product CodeFAP
Date Received2001-09-07
Model NumberNA
Catalog Number580214
Lot NumberUNK
ID NumberNA
OperatorLAY USER/PATIENT
Device AvailabilityY
Device Eval'ed by MfgrY
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key340458
ManufacturerRUSCH MANUFACTURING UK LTD, RUSCH LURGAN
Manufacturer AddressPORTADOWN ROAD NORTHERN IRELAND UK BT66 8RD
Baseline Brand NameRECTAL BALLOON
Baseline Model NoNA
Baseline Catalog No580214
Baseline IDNA
Baseline Shelf Life Contained*
Baseline Shelf Life [Months]*
Baseline PMA FlagN
Baseline 510K PMNY
Premarket NotificationK962472
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
10 2001-09-07

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