AMIELLE SM2100 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2003-12-22 for AMIELLE SM2100 * manufactured by Owen Mumford, Ltd..

Event Text Entries

[16367089] Pt was using the vaginal trainer, when the handle became detached. Pt had the trainer removed with the aid of forceps.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8021764-2003-00005
MDR Report Key505563
Report Source08
Date Received2003-12-22
Date of Report2003-11-17
Date Mfgr Received2003-10-20
Date Added to Maude2004-01-12
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Manufacturer ContactCHRIS FREER
Manufacturer StreetBROOK HILL
Manufacturer CityWOODSTOCK, OXCAN OX201TU
Manufacturer Country*
Manufacturer PostalOX20 1TU
Manufacturer Phone4199381202
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Remedial ActionIN
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameAMIELLE
Generic NameVAGINAL TRAINER
Product CodeHDX
Date Received2003-12-22
Model NumberSM2100
Catalog Number*
Lot NumberG8T
ID Number*
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key494433
ManufacturerOWEN MUMFORD, LTD.
Manufacturer AddressBROOK HILL WOODSTOCK, OXCA, ENGLAND UK OX20 1TU
Baseline Brand NameAMIELLE VAGINAL TRAINER KIT
Baseline Model NoSM2100
Baseline Device FamilyAMIELLE
Baseline Shelf Life Contained*
Baseline Shelf Life [Months]*
Baseline PMA FlagN
Baseline 510K PMNN
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2003-12-22

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.