MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2007-12-21 for HYSON 0231 manufactured by Coopersurgical, Inc..
[748865]
During leiomyoma procedures, two patients developed pulmonary edema.
Patient Sequence No: 1, Text Type: D, B5
[7901185]
Two lots have been identified as the probable lots used: ns40228 mgf 8/2007 exp 8/2010. Ns40224 mfg 5/2006 exp 5/2009. Inventory of both lots have been exhausted. There have been no previous complaints for either lot. Preliminary batch records review results have not uncovered any anomalies. The user facility indicated one of the patients had an underlying cardiac condition that may have contributed to the event. The other patient was believed to be an otherwise healthy individual. Both patients have since recovered.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1216677-2007-00032 |
| MDR Report Key | 968707 |
| Report Source | 06 |
| Date Received | 2007-12-21 |
| Date of Report | 2007-12-10 |
| Date of Event | 2007-11-12 |
| Date Mfgr Received | 2007-11-14 |
| Date Added to Maude | 2008-01-02 |
| 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 Contact | THOMAS WILLIAMS |
| Manufacturer Street | 95 CORPORATE DR. |
| Manufacturer City | TRUMBULL CT 06611 |
| Manufacturer Postal | 06611 |
| Manufacturer Phone | 2036015200 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HYSON |
| Generic Name | HYSTEROSCOPY FLUID |
| Product Code | LTA |
| Date Received | 2007-12-21 |
| Model Number | 0231 |
| 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 | 940370 |
| Manufacturer | COOPERSURGICAL, INC. |
| Manufacturer Address | TRUMBULL CT |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-12-21 |