MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2008-06-06 for EXOGEN COUPLING GEL 71034124 manufactured by Smith & Nephew, Inc., Orthopaedic Div..
[15162238]
It was reported that while using an exogen unit, the patient developed crusted lesions on the outside of his foot. The lesions progressed into the development of staph infection of the affected area. Patient is suspected to have a localized reaction to the coupling gel. The physician's plan of action is to treat the staph and then continue the exogen therapy using mineral oil instead of the gel. The physician did not contribute the staph infection to the coupling gel.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1020279-2008-00169 |
| MDR Report Key | 1058309 |
| Report Source | 00 |
| Date Received | 2008-06-06 |
| Date of Report | 2008-05-29 |
| Date of Event | 2008-05-29 |
| Date Mfgr Received | 2008-05-29 |
| Date Added to Maude | 2008-06-13 |
| 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 | UNKNOWN |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. PHILIP EMMERT,SPLST II,REG.COMP. |
| Manufacturer Street | 1450 BROOKS ROAD |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal | 38116 |
| Manufacturer Phone | 9013995296 |
| Manufacturer G1 | SMITH & NEPHEW, INC. |
| Manufacturer Street | 1450 BROOKS ROAD |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38116 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EXOGEN COUPLING GEL |
| Generic Name | ULTRASOUND COUPLING GEL |
| Product Code | MUI |
| Date Received | 2008-06-06 |
| Model Number | NA |
| Catalog Number | 71034124 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1026635 |
| Manufacturer | SMITH & NEPHEW, INC., ORTHOPAEDIC DIV. |
| Manufacturer Address | 1450 BROOKS ROAD MEMPHIS TN 38116 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-06-06 |