MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2010-06-20 for EXOGEN COUPLING GEL 81025200 manufactured by Brooks Manufacturing Site.
[1538291]
It was reported that a patient developed red, flaky, inflammed skin while using the exogen device. The patient visited a dermatologist for treatement; however, the causal relationhip between the symptoms and the device could not be determined.
Patient Sequence No: 1, Text Type: D, B5
[8618660]
Smith & nephew, inc. Is submitting this report pursuant to the provisions of 21 cfr, part 803. This report may be based upon information which smith & nephew, inc. Has not been able to investigate or verify prior to the required reporting date. This report does not reflect a conclusion by fda, smith & nephew, inc. , or its employees, that the report constitutes an admission that the device, smith & nephew, inc. , or its employees caused or contributed to the potential event described in this reportthe actual lot number of the gel was not provided by the customer and the product will not be returned for evaluation purposes.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1020279-2010-00169 |
| MDR Report Key | 1729127 |
| Report Source | 08 |
| Date Received | 2010-06-20 |
| Date of Report | 2010-06-15 |
| Date of Event | 2010-05-20 |
| Date Mfgr Received | 2010-06-15 |
| Date Added to Maude | 2010-06-21 |
| 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 | MR PHILLIP EMMERT |
| Manufacturer Street | 1450 E. BROOKS RD |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal | 38116 |
| Manufacturer Phone | 9013995296 |
| Manufacturer G1 | BROOKS MANUFACTURING SITE |
| 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 COUPLING GEL |
| Generic Name | ULTRASOUND COUPLING GEL |
| Product Code | MUI |
| Date Received | 2010-06-20 |
| Catalog Number | 81025200 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BROOKS MANUFACTURING SITE |
| Manufacturer Address | 1450 BROOKS ROAD MEMPHIS TN 38116 US 38116 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-06-20 |