MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-04-03 for EXOGEN 71034100 manufactured by Smith & Nephew Orthopaedics, Inc..
[2572361]
It was reported that patient's x-rays indicate that parosteal osteosarcoma of the right proximal humerus has returned.
Patient Sequence No: 1, Text Type: D, B5
[2705167]
It was initially reported that patient's x-ray indicated parosteal osteosarcoma of the right humeus has returned, which the treating physician reported there was no casual relationship to the use of the exogen device.
Patient Sequence No: 1, Text Type: D, B5
[9710587]
.
Patient Sequence No: 1, Text Type: N, H10
[9997812]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1020279-2012-00210 |
| MDR Report Key | 2515175 |
| Report Source | 07 |
| Date Received | 2012-04-03 |
| Date of Report | 2012-04-03 |
| Date of Event | 2012-04-03 |
| Date Mfgr Received | 2012-04-03 |
| Device Manufacturer Date | 2011-06-01 |
| Date Added to Maude | 2012-04-03 |
| 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 | MRS. LAKEISHA UPCHURCH |
| Manufacturer Street | 1450 EAST BROOKS ROAD |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal | 38116 |
| Manufacturer Phone | 9013991122 |
| Manufacturer G1 | SMITH & NEPHEW, INC. |
| Manufacturer Street | 1450 EAST BROOKS ROAD |
| 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 | 4000+ SYSTEM |
| Product Code | LPQ |
| Date Received | 2012-04-03 |
| Catalog Number | 71034100 |
| Lot Number | 11FM02549 |
| 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 | SMITH & NEPHEW ORTHOPAEDICS, INC. |
| Manufacturer Address | 1450 BROOKS ROAD MEMPHIS TN 38116 US 38116 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-04-03 |