MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2010-03-18 for EXOGEN EXOGEN 4000+MOU 71034101 manufactured by Brooks Manufacturing Site.
[20215585]
Approximately 3 months ago, patient underwent left wrist surgery and treatment with the exogen device. After the removal of the cast, patient noticed a skin discoloration and an open wound area on the treatment site.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1020279-2010-00079 |
| MDR Report Key | 1635390 |
| Report Source | 05,07 |
| Date Received | 2010-03-18 |
| Date of Report | 2010-02-19 |
| Date of Event | 2010-02-18 |
| Date Mfgr Received | 2010-02-18 |
| Device Manufacturer Date | 2009-11-01 |
| Date Added to Maude | 2010-03-23 |
| 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 | SANDI LANE |
| Manufacturer Street | 1450 BROOKS RD. |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal | 38116 |
| Manufacturer Phone | 9013995712 |
| Manufacturer G1 | BROOKS MANUFACTURING SITE |
| Manufacturer Street | 1450 BROOKS RD. |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38116 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EXOGEN |
| Generic Name | BONE HEALING SYSTEM / LPQ |
| Product Code | LPQ |
| Date Received | 2010-03-18 |
| Returned To Mfg | 2010-03-06 |
| Model Number | EXOGEN 4000+MOU |
| Catalog Number | 71034101 |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BROOKS MANUFACTURING SITE |
| Manufacturer Address | MEMPHIS TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-03-18 |