MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,08 report with the FDA on 2005-08-25 for E.P.T. PREGNANCY TEST UNK manufactured by Unipath Limite.
[21951608]
Family member called to say pt had to be taken to the clinic as patient accidentally put the test in their vagina. They said pt was bleeding. No other information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611939-2005-00017 |
| MDR Report Key | 630447 |
| Report Source | 04,08 |
| Date Received | 2005-08-25 |
| Date of Report | 2005-08-16 |
| Date of Event | 2005-07-27 |
| Date Mfgr Received | 2005-08-16 |
| Date Added to Maude | 2005-08-29 |
| 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 | 2005-08-25 |
| 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 | A |
| Device Sequence No | 1 |
| Device Event Key | 620049 |
| Manufacturer | UNIPATH LIMITE |
| Manufacturer Address | * BEDFORD UK MK44 3UP |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-08-25 |