MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-10-29 for BABY GENDER MENTOR TEST UNK manufactured by Acu-gen Lab.
[501671]
Reporter's daughter purchased the baby gender mentor test from acu-gen lab. Instead of the tech calling to confirm that she was having a boy or girl, they diagnosed her baby, over the phone, with chromosonal abnormalities. This type of testing was not supposed to be done with her blood sample, nor should she have been notified by a complete stranger, who claims to be a dr, via telephone, to be told something of this nature. The advertisement for this test, only states that they will check for the babie's "gender", nothing else. Reporter's daughter's ob dr has done tests at the correct time, for "reliable" results, and has found nothing whatever wrong with her baby to date.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1037898 |
| MDR Report Key | 747091 |
| Date Received | 2005-10-29 |
| Date of Report | 2005-10-29 |
| Date of Event | 2005-08-05 |
| Date Added to Maude | 2006-08-15 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| 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 | BABY GENDER MENTOR TEST |
| Generic Name | GENDER FINDING BLOOD TEST |
| Product Code | LIM |
| Date Received | 2005-10-29 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Device Expiration Date | 2005-01-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 734874 |
| Manufacturer | ACU-GEN LAB |
| Manufacturer Address | * * MA * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-10-29 |