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. CERTAINTY PREGNANCY TEST UNK manufactured by Unipath Limited.
[386465]
A caller to the distributor's helpline stated pt inserted the test into their vagina, cutting the inside of their vagina. The caller who claimed to be the patient's family member stated they did not have the test and could not provide the lot number or expiration date. They did not want to leave contact information. They stated patient was seen in the clinic and was treated with "salve" for the tear in their vagina.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611939-2005-00016 |
| MDR Report Key | 630443 |
| Report Source | 04,08 |
| Date Received | 2005-08-25 |
| Date of Report | 2005-08-09 |
| Date of Event | 2005-08-01 |
| Date Mfgr Received | 2005-08-09 |
| 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. CERTAINTY PREGNANCY TEST |
| Generic Name | HOME PREGNANCY TEST |
| Product Code | JHJ |
| Date Received | 2005-08-25 |
| Model Number | NA |
| 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 | 620045 |
| Manufacturer | UNIPATH LIMITED |
| Manufacturer Address | * BEDFORD UK MK44 3UP |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-08-25 |