MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-03-03 for OSOM CARD PREGNANCY TEST 102 manufactured by Genzyme Diagnostics.
[359979]
Pt tested negative on the osom card pregnancy test on an unspecified date. The test was performed on urine (specific gravity unknown). According to the reporter, the test "turned positive well after the read time" and the site had used "a cytology brush for a pap smear that is not recommended for a pregnant pt. " the pt's last menstrual period was not provided. The reporter could not confirm that confirmatory human chorionic gonadotropin (hcg) or pregnancy testing was performed. To date, no fetal or pt injury has been reported. No information was provided on the pt's outcome.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2030538-2004-00003 |
| MDR Report Key | 531820 |
| Date Received | 2004-03-03 |
| Date of Report | 2004-03-02 |
| Date of Event | 2004-02-01 |
| Date Mfgr Received | 2004-02-06 |
| Date Added to Maude | 2004-06-30 |
| 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 Contact | ROBERT YOCHER |
| Manufacturer Street | ONE KENDALL SQUARE |
| Manufacturer City | CAMBRIDGE MA 021391562 |
| Manufacturer Country | US |
| Manufacturer Postal | 021391562 |
| Manufacturer Phone | 6172527500 |
| Manufacturer G1 | GENZYME DIAGNOSTICS |
| Manufacturer Street | 6659 TOP GUN |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92121 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OSOM CARD PREGNANCY TEST |
| Generic Name | NI |
| Product Code | JHJ |
| Date Received | 2004-03-03 |
| Model Number | 102 |
| Catalog Number | 102 |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | I |
| Device Sequence No | 1 |
| Device Event Key | 521069 |
| Manufacturer | GENZYME DIAGNOSTICS |
| Manufacturer Address | 6659 TOP GUN SAN DIEGO CA 92121 US |
| Baseline Brand Name | OSOM CARD PREGNANCY TEST |
| Baseline Generic Name | NI |
| Baseline Model No | 102 |
| Baseline Catalog No | 102 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2004-03-03 |