RIGID CURVE POSITIONER RCP

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 2002-09-04 for RIGID CURVE POSITIONER RCP manufactured by Power Medical Interventions.

Event Text Entries

[15007279] Difficulty inserting 29mm dlu into rectum; three dlus detached from "flexshft" at the rectal stump. Required much work to access and retrieve detached dlus transanally.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2532140-2002-00007
MDR Report Key417914
Report Source05
Date Received2002-09-04
Date of Report2002-09-04
Date of Event2002-02-12
Date Mfgr Received2002-02-12
Date Added to Maude2002-09-24
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 ContactLARRY POTTER
Manufacturer Street110 UNION SQUARE DRIVE
Manufacturer CityNEW HOPE PA 18938
Manufacturer CountryUS
Manufacturer Postal18938
Manufacturer Phone2677758100
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameRIGID CURVE POSITIONER
Generic NamePROBE DIRECTOR
Product CodeEXX
Date Received2002-09-04
Returned To Mfg2002-02-21
Model NumberNA
Catalog NumberRCP
Lot NumberNA
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key406949
ManufacturerPOWER MEDICAL INTERVENTIONS
Manufacturer Address110 UNION SQUARE DRIVE NEW HOPE PA 18938 US
Baseline Brand NameRIGID CURVE POSITIONER
Baseline Generic NamePROBE DIRECTOR
Baseline Model NoNA
Baseline Catalog NoRCP
Baseline ID*


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Required No Informationntervention 2002-09-04

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