MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-08-13 for MAINLINE CONFIRMS HCG ONE-STEP PREGNANCY TEST * 3029-25 manufactured by Mainline Tech Inc.
[15163252]
Pregnancy test gave false positive more than 3 times.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1129143 |
| MDR Report Key | 1129143 |
| Date Received | 2008-08-13 |
| Date of Report | 2008-08-13 |
| Date of Event | 2007-06-26 |
| Report Date | 2008-08-13 |
| Date Reported to FDA | 2008-08-13 |
| Date Added to Maude | 2008-08-22 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAINLINE CONFIRMS HCG ONE-STEP PREGNANCY TEST |
| Generic Name | LAB TEST, PREGNANCY |
| Product Code | JHJ |
| Date Received | 2008-08-13 |
| Returned To Mfg | 2008-08-08 |
| Model Number | * |
| Catalog Number | 3029-25 |
| Lot Number | 96380 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 1123201 |
| Manufacturer | MAINLINE TECH INC |
| Manufacturer Address | 3985 RESEARCH PARK DR ANN ARBOR MI 48108 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-08-13 |