MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-23 for EQUALIZER WALKER MEDIUM BLACK W0600BLK manufactured by Ossur Americas.
[52840035]
Patient claims she developed a contact allergy while wearing the equalizer walker boot which then spread to her other foot and to her hands. Patient made a visit to the doctor and was prescribed steroids and other medications. Patient is no longer wearing the boot.
Patient Sequence No: 1, Text Type: D, B5
[57632481]
Patient Sequence No: 1, Text Type: N, H10
[57632482]
Patient claims she developed a contact allergy while wearing the equalizer walker boot. Patient made a visit to the doctor and was prescribed steroids and other medications. The rash got worse when she started the medication and it then spread to her other foot and hands. She stopped wearing the product and the rash seems to be clearing up.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2085446-2016-00005 |
| MDR Report Key | 5897898 |
| Date Received | 2016-08-23 |
| Date of Report | 2016-10-17 |
| Date of Event | 2016-07-27 |
| Date Mfgr Received | 2016-08-02 |
| 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 | 9493823741 |
| 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 | EQUALIZER WALKER MEDIUM BLACK |
| Generic Name | JOINT, ANKLE, EXTERNAL BRACE |
| Product Code | ITW |
| Date Received | 2016-08-23 |
| Model Number | W0600BLK |
| Catalog Number | W0600BLK |
| 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 |