MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2007-10-10 for WALLACH INSEMINATOR 920012 manufactured by Wallach Surgical Devices, Inc..
[14867575]
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.
Patient Sequence No: 1, Text Type: D, B5
[15452173]
Could not replace the reported problem in samples from the same lot.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219739-2007-00004 |
| MDR Report Key | 927868 |
| Report Source | 06 |
| Date Received | 2007-10-10 |
| Date of Report | 2007-09-26 |
| Date of Event | 2007-09-13 |
| Date Mfgr Received | 2007-09-13 |
| Device Manufacturer Date | 2006-11-01 |
| Date Added to Maude | 2007-12-07 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 235 EDISON ROAD |
| Manufacturer City | ORANGE CT 06477 |
| Manufacturer Country | US |
| Manufacturer Postal | 06477 |
| Manufacturer Phone | 2037992000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WALLACH INSEMINATOR |
| Generic Name | NONE |
| Product Code | MFD |
| Date Received | 2007-10-10 |
| Model Number | NA |
| Catalog Number | 920012 |
| Lot Number | 462006-200911 |
| Device Expiration Date | 2009-11-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 923794 |
| Manufacturer | WALLACH SURGICAL DEVICES, INC. |
| Manufacturer Address | ORANGE CT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-10-10 |