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..
[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
Report Number | 8021764-2003-00005 |
MDR Report Key | 505563 |
Report Source | 08 |
Date Received | 2003-12-22 |
Date of Report | 2003-11-17 |
Date Mfgr Received | 2003-10-20 |
Date Added to Maude | 2004-01-12 |
Event Key | 0 |
Report Source Code | Manufacturer report |
Manufacturer Link | Y |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 3 |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 0 |
Manufacturer Contact | CHRIS FREER |
Manufacturer Street | BROOK HILL |
Manufacturer City | WOODSTOCK, OXCAN OX201TU |
Manufacturer Country | * |
Manufacturer Postal | OX20 1TU |
Manufacturer Phone | 4199381202 |
Manufacturer G1 | * |
Manufacturer Street | * |
Manufacturer City | * |
Manufacturer Country | * |
Single Use | 3 |
Remedial Action | IN |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | AMIELLE |
Generic Name | VAGINAL TRAINER |
Product Code | HDX |
Date Received | 2003-12-22 |
Model Number | SM2100 |
Catalog Number | * |
Lot Number | G8T |
ID Number | * |
Operator | LAY USER/PATIENT |
Device Availability | N |
Device Eval'ed by Mfgr | R |
Implant Flag | N |
Date Removed | * |
Device Sequence No | 1 |
Device Event Key | 494433 |
Manufacturer | OWEN MUMFORD, LTD. |
Manufacturer Address | BROOK HILL WOODSTOCK, OXCA, ENGLAND UK OX20 1TU |
Baseline Brand Name | AMIELLE VAGINAL TRAINER KIT |
Baseline Model No | SM2100 |
Baseline Device Family | AMIELLE |
Baseline Shelf Life Contained | * |
Baseline Shelf Life [Months] | * |
Baseline PMA Flag | N |
Baseline 510K PMN | N |
Baseline Preamendment | N |
Baseline Transitional | N |
510k Exempt | N |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other | 2003-12-22 |