MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2013-05-28 for EXOGEN 4000+ SYSTEM EXPORT 71034150 manufactured by Bioventus Llc.
[15015394]
Adverse event: thrombosis. While using the exogen device to treat a fracture of the humerus, the pt experienced pain in her shoulder and neck. Later, she was diagnosed with thrombosis. Bioventus have made several attempts to collect additional complaint info from the pt and hospital, but were unsuccessful.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010203571-2013-00001 |
| MDR Report Key | 3267877 |
| Report Source | 01 |
| Date Received | 2013-05-28 |
| Date of Report | 2013-05-17 |
| Date of Event | 2013-05-03 |
| Date Mfgr Received | 2013-05-04 |
| Date Added to Maude | 2013-08-08 |
| 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 | KANICHY ROYSTON |
| Manufacturer Street | 1900 CHARLES BRYAN RD SUITE 275 |
| Manufacturer City | CORDOVA TN 38016 |
| Manufacturer Country | US |
| Manufacturer Postal | 38016 |
| Manufacturer Phone | 9013412930 |
| Manufacturer G1 | BIOVENTUS LLC |
| Manufacturer Street | 1900 CHARLES BRYAN RD SUITE 275 |
| Manufacturer City | CORDOVA TN 38016 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38016 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EXOGEN 4000+ SYSTEM EXPORT |
| Generic Name | EXOGEN 4000+ |
| Product Code | LPQ |
| Date Received | 2013-05-28 |
| Model Number | 71034150 |
| Catalog Number | 71034150 |
| Lot Number | ASKU |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOVENTUS LLC |
| Manufacturer Address | CORDOVA TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-05-28 |