MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2006-03-16 for E.P.T UNK manufactured by Unipath Ltd..
[15491893]
Caller states that her daughter inserted the test into her vagina, instead of urinating on it. Caller states that she pulled the test out and tore some of the skin her vagina. There was some bleeding. Caller took daughter to the clinic. Would not leave contact information or clinic information.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611939-2006-00006 |
| MDR Report Key | 688700 |
| Report Source | 04 |
| Date Received | 2006-03-16 |
| Date of Report | 2006-03-06 |
| Date Mfgr Received | 2006-03-06 |
| Date Added to Maude | 2006-03-20 |
| 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 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | LOUISE ROBERTS,MANAGER |
| Manufacturer Street | PRIORY BUSINESS PARK |
| Manufacturer City | BEDFORD MK443UP |
| Manufacturer Country | UK |
| Manufacturer Postal | MK44 3UP |
| Manufacturer Phone | 234835564 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | E.P.T |
| Generic Name | HOME PREGNANCY TEST |
| Product Code | LCK |
| Date Received | 2006-03-16 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| 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 | 677903 |
| Manufacturer | UNIPATH LTD. |
| Manufacturer Address | * BEDFORD UK MK44 3UP |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-03-16 |