FDA Adverse Event
Malfunction
Summary report: N
WALLACH INSEMINATOR
MDR report key: 927868
·
Received October 10, 2007
Report
- Report Number
- 1219739-2007-00004
- Event Type
- Malfunction
- Date Received
- October 10, 2007
- Date of Event
- September 13, 2007
- Report Date
- September 26, 2007
- Manufacturer
- WALLACH SURGICAL DEVICES, INC.
- Product Code
- MFD
- PMA / PMN Number
- K984306
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RI, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
COULD NOT REPLACE THE REPORTED PROBLEM IN SAMPLES FROM THE SAME LOT.
Description of Event or Problem · 1
CATHETER OF INSEMINATION DEVICE WOULD NOT STAY ON SYRINGE THAT WAS SUPPLIED WITH IT. WHEN IT WAS INSERTED INTO THE PATIENT, THE CATHETER FELL OFF THE SYRINGE AND INTO THE VAGINA CAUSING THE SPECIMEN TO LEAK OUT. THE CATHETER HAD TO BE RETRIEVED WITH FORCEPS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | WALLACH INSEMINATOR | NONE | MFD | WALLACH SURGICAL DEVICES, INC. | NA | 462006-200911 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Other |