MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2009-08-07 for PSI-TEC III ASPIRATION PLATFORM 110V PT-PLT-III-110 manufactured by Byron Medical.
[1107073]
Per a medwatch from the hospital, the pt was undergoing correction of gynecomastia with bilateral mastectomy and ultrasonic liposuction when a small burn was noted. The area was excised and sutured.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1645337-2009-00041 |
| MDR Report Key | 1437087 |
| Report Source | 06 |
| Date Received | 2009-08-07 |
| Date of Report | 2009-08-06 |
| Date of Event | 2009-06-26 |
| Date Mfgr Received | 2009-07-15 |
| Date Added to Maude | 2009-11-17 |
| 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 | CHRISTY BABB |
| Manufacturer Street | 3041 SKYWAY CIRCLE NORTH |
| Manufacturer City | IRVING TX 75038 |
| Manufacturer Country | US |
| Manufacturer Postal | 75038 |
| Manufacturer Phone | 9722526060 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PSI-TEC III ASPIRATION PLATFORM 110V |
| Generic Name | ASPIRATION PLATFORM |
| Product Code | GDM |
| Date Received | 2009-08-07 |
| Catalog Number | PT-PLT-III-110 |
| Lot Number | 02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BYRON MEDICAL |
| Manufacturer Address | TUCSON AZ 85705 US 85705 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-08-07 |