MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-05-06 for EXOGEN EXOGEN 4000+ SYSTEM 71034100 manufactured by Smith & Nephew, Orthopedics.
[2025523]
It was reported that a patient developed a mild skin irritation while using the exogen device. It was noted by the treating the patient did follow usage instructions. The device was not faulted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1020279-2011-00150 |
| MDR Report Key | 2080424 |
| Report Source | 07 |
| Date Received | 2011-05-06 |
| Date of Report | 2011-05-06 |
| Date of Event | 2011-04-20 |
| Date Mfgr Received | 2011-04-20 |
| Date Added to Maude | 2011-05-09 |
| 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 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. CONNIE BOANE |
| Manufacturer Street | 1450 E. BROOKS ROAD |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal | 38116 |
| Manufacturer Phone | 9013995985 |
| Manufacturer G1 | SMITH & NEPHEW, ORTHOPEDICS |
| Manufacturer Street | 1450 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 | BONE GROWTH STIMULATOR |
| Product Code | LPQ |
| Date Received | 2011-05-06 |
| Model Number | EXOGEN 4000+ SYSTEM |
| Catalog Number | 71034100 |
| Lot Number | 0910051106E |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW, ORTHOPEDICS |
| Manufacturer Address | 1450 BROOKS ROAD MEMPHIS TN 38116 US 38116 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-05-06 |