MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,08 report with the FDA on 2005-05-18 for E.P.T PREGNANCY TEST UNK manufactured by Unipath Ltd..
[371929]
A caller to the deistributor's help line stated that patient accidentally inserted an e. P. T pregnancy test. Pt stated that pt cut herself in the area. They took pt to the clinic and was given ointment to apply. The caller said pt is feeling better. They wanted to know how the test should be performed. The caller did not wish to leave any further info. Pt threw away the box and test is not lot. No. Or expiry is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611939-2005-00010 |
| MDR Report Key | 603767 |
| Report Source | 04,08 |
| Date Received | 2005-05-18 |
| Date of Report | 2005-04-28 |
| Date of Event | 2005-04-01 |
| Date Mfgr Received | 2005-04-28 |
| Date Added to Maude | 2005-05-20 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | LOUIS ROBERTS, MANAGER |
| Manufacturer Street | * |
| 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 PREGNANCY TEST |
| Generic Name | HOME PREGNANCY TEST |
| Product Code | JHJ |
| Date Received | 2005-05-18 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 593610 |
| Manufacturer | UNIPATH LTD. |
| Manufacturer Address | * BEDFORD UK MK44 3UP |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-05-18 |