MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-06-08 for INNOVACON FHC-102 NA manufactured by Innovacon, Inc.
[624875]
Healthcare professional using the device -fhc-102- got a negative result with a urine specimen. Based on the tests results, an iud was inserted. When a subsequent ultrasound was performed to check placement of the iud, the pregnancy was confirmed. The iud was placed and removed on the same day. Six days later, the pt developed severe abdominal cramping. Two days later, the pt spontaneously aborted -miscarried- the fetus.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5002555 |
| MDR Report Key | 864331 |
| Date Received | 2007-06-08 |
| Date of Report | 2007-06-08 |
| Date of Event | 2007-04-18 |
| Date Added to Maude | 2007-06-14 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INNOVACON |
| Generic Name | ONE STEP PREGNANCY TEST DEVICE -URINE- |
| Product Code | JHJ |
| Date Received | 2007-06-08 |
| Model Number | FHC-102 |
| Catalog Number | NA |
| Lot Number | HCG7010070 |
| ID Number | NA |
| Device Expiration Date | 2009-01-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 846853 |
| Manufacturer | INNOVACON, INC |
| Manufacturer Address | SAN DIEGO CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-06-08 |