MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-11-04 for EXOGEN 4000+ 71034100 manufactured by Smith & Nephew Orthopaedics.
[2229798]
It was reported that a patient experienced mild to moderate skin irritation while using the device.
Patient Sequence No: 1, Text Type: D, B5
[9382664]
Based on the information provided a revision surgery was performed involving a smith and nephew product, it is concluded that in accordance with the regulations set forth under 21 cfr 803, it is concluded that this is a reportable event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1020279-2011-00459 |
| MDR Report Key | 2324634 |
| Report Source | 07 |
| Date Received | 2011-11-04 |
| Date of Report | 2011-10-20 |
| Date of Event | 2011-10-16 |
| Date Mfgr Received | 2011-10-20 |
| Date Added to Maude | 2011-11-04 |
| 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. CONNIE MCBROOM |
| Manufacturer Street | 1450 E. BROOKS ROAD |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal | 38116 |
| Manufacturer Phone | 9013995985 |
| Manufacturer G1 | SMITH & NEPHEW ORTHOPAEDICS |
| 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 4000+ |
| Generic Name | EXOGEN 4000+ |
| Product Code | LPQ |
| Date Received | 2011-11-04 |
| Catalog Number | 71034100 |
| Lot Number | 1210065258E |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW ORTHOPAEDICS |
| Manufacturer Address | 1450 BROOKS ROAD MEMPHIS TN 38116 US 38116 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2011-11-04 |