MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2010-09-07 for EXOGEN COUPLING GEL 81025200 manufactured by Brooks Manufacturing Site.
[1710058]
It was reported that a patient noticed redness and a sore at the gel treatment site. The patient sought medical treatment and received a steroid ointment for the reported symptoms.
Patient Sequence No: 1, Text Type: D, B5
[8755503]
Actual product in question will not be returned for evaluation purposes.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1020279-2010-00252 |
| MDR Report Key | 1827315 |
| Report Source | 05,07 |
| Date Received | 2010-09-07 |
| Date of Report | 2010-08-20 |
| Date of Event | 2010-07-28 |
| Date Mfgr Received | 2010-08-20 |
| Date Added to Maude | 2010-09-08 |
| 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 | SANDI LANE |
| Manufacturer Street | 1450 BROOKS ROAD |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal | 38116 |
| Manufacturer Phone | 9013995712 |
| 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 | 2010-09-07 |
| Catalog Number | 81025200 |
| Lot Number | UNK |
| 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 | 2010-09-07 |