MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2015-08-11 for E.P.T. ANALOG EARLY PREGNANCY TEST UNK manufactured by Akere (shanghai) Diagnostics Co., Ltd..
[23149927]
The mother reported her daughter used one e. P. T. Analog early pregnancy test once, vaginally, to test for possible pregnancy on (b)(6) 2015. On (b)(6) 2015, contrary to the product's instructions for use, the patient inserted test into vagina, the test became stuck. When she attempted to remove it, she tore her vaginal wall and began to experience vaginal bleeding. The mother took her to the hospital where they sedated her, removed the test surgically and gave her some pain killers and cream. At the hospital, patient was confirmed pregnant by a blood test. The mother reports her daughter was not admitted and was at the hospital for treatment for less than 24 hours. The mother reported that her daughter is currently not taking medications and has no medical history. The mother reported that her daughter was pregnant when she used the e. P. T. Analog early pregnancy test. The patient's pregnancy due date is unk.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005128563-2015-00001 |
| MDR Report Key | 5003088 |
| Report Source | LITERATURE |
| Date Received | 2015-08-11 |
| Date of Report | 2015-08-07 |
| Date of Event | 2015-07-01 |
| Date Mfgr Received | 2015-07-01 |
| Date Added to Maude | 2015-08-14 |
| 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 | 3 |
| Manufacturer Street | 660 WHITE PLAINS RD |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145248700 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | E.P.T. ANALOG EARLY PREGNANCY TEST |
| Generic Name | HCG PREGNANCY TEST, OTC |
| Product Code | LCX |
| Date Received | 2015-08-11 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AKERE (SHANGHAI) DIAGNOSTICS CO., LTD. |
| Manufacturer Address | NO. 151 LIBING ROAD SHANGHAI, SHANGHAI 201203 CH 201203 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-08-11 |