MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-23 for GAMEDAY ANKLE BRACE WITH FIGURE 8 STRAP HC000697 manufactured by Ossur Americas.
[52839251]
Patient Sequence No: 1, Text Type: N, H10
[52839252]
Patient wearing the gameday ankle brace with the figure-8 strap off and on for 1-2 weeks developed skin irritation and a rash right above her ankle. She tried wearing the product with and without a sock and still felt skin irritation. Patient visited a dermatologist on (b)(6) 2016 and was provided with a prescription to use for 4 weeks. Patient did not have the name of the prescription. The rash caused a scar which will require future bleaching treatments with the dermatologist.
Patient Sequence No: 1, Text Type: D, B5
[57639031]
Patient Sequence No: 1, Text Type: N, H10
[57639032]
Patient wearing the gameday ankle brace with the figure-8 strap off and on for 1-2 weeks developed skin irritation and a rash right above her ankle. She tried wearing the product with and without a sock and still felt skin irritation. Patient visited a dermatologist on (b)(6) 2016 and was provided with a prescription to use for 4 weeks. Patient did not have the name of the prescription. The rash caused a scar which will require future bleaching treatments with the dermatologist.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2085446-2016-00006 |
| MDR Report Key | 5898025 |
| Date Received | 2016-08-23 |
| Date of Report | 2016-10-17 |
| Date of Event | 2016-08-01 |
| Date Mfgr Received | 2016-08-11 |
| Date Added to Maude | 2016-08-23 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. KAREN MONTES |
| Manufacturer Street | 27051 TOWNE CENTRE DRIVE |
| Manufacturer City | FOOTHILL RANCH CA 92610 |
| Manufacturer Country | US |
| Manufacturer Postal | 92610 |
| Manufacturer Phone | 9492757557 |
| Manufacturer G1 | OSSUR AMERICAS |
| Manufacturer Street | 27051 TOWNE CENTRE |
| Manufacturer City | FOOTHILL RANCH CA 92610 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92610 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GAMEDAY ANKLE BRACE WITH FIGURE 8 STRAP |
| Generic Name | JOINT, ANKLE, EXTERNAL BRACE |
| Product Code | ITW |
| Date Received | 2016-08-23 |
| Model Number | HC000697 |
| Catalog Number | HC000697 |
| Lot Number | 510 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OSSUR AMERICAS |
| Manufacturer Address | 27051 TOWNE CENTRE FOOTHILL RANCH CA 92610 US 92610 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-08-23 |