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 |