MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1999-01-14 for RETROGUARD (STERILE) 4007100 NA manufactured by American Omni Medical, Inc..
[174198]
The customer reported that the retroguard valve leaked upon initiation of bypass. The case was stopped while the valve was cut out and replaced. The case was then completed with the new valve without incident. No pt injuries were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1649914-1999-00001 |
| MDR Report Key | 206869 |
| Report Source | 05,06 |
| Date Received | 1999-01-14 |
| Date of Report | 1999-01-14 |
| Date of Event | 1998-12-10 |
| Date Mfgr Received | 1998-12-14 |
| Device Manufacturer Date | 1998-04-01 |
| Date Added to Maude | 1999-01-22 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RETROGUARD (STERILE) |
| Generic Name | ONE-WAY ARTERIAL CHECK VALVE |
| Product Code | MJJ |
| Date Received | 1999-01-14 |
| Model Number | 4007100 |
| Catalog Number | NA |
| Lot Number | 980314S |
| ID Number | NA |
| Device Expiration Date | 2002-04-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 200801 |
| Manufacturer | AMERICAN OMNI MEDICAL, INC. |
| Manufacturer Address | 2930 G GRACE LANE COSTA MESA CA 92626 US |
| Baseline Brand Name | RETROGUARD (STERILE) |
| Baseline Generic Name | RETROGUARD |
| Baseline Model No | 4007100 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | 48 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K922356 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1999-01-14 |