MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2017-09-28 for UNLOADER ONE B-240529713 manufactured by Ossur Mexico.
[87636768]
Patient wearing unloader one knee brace claims the product was causing pain on his affected side and he went to the emergency room for an infection.
Patient Sequence No: 1, Text Type: D, B5
[109784459]
Patient Sequence No: 1, Text Type: N, H10
[109784460]
Patient wearing unloader one knee brace claims the product was causing pain on his affected side and he went to the emergency room for an infection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008523132-2017-00007 |
| MDR Report Key | 6900806 |
| Report Source | DISTRIBUTOR |
| Date Received | 2017-09-28 |
| Date of Report | 2017-09-18 |
| Date Mfgr Received | 2017-08-23 |
| Date Added to Maude | 2017-09-28 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. KAREN MONTES |
| Manufacturer Street | 27051 TOWNE CENTRE |
| Manufacturer City | FOOTHILL RANCH CA 92610 |
| Manufacturer Country | US |
| Manufacturer Postal | 92610 |
| Manufacturer Phone | 9492757557 |
| Manufacturer G1 | OSSUR MEXICO |
| Manufacturer Street | BOULEVARD HECTOR TERAN TERAN 2 EDIFICIO #1 COL. CANON DEL PAD |
| Manufacturer City | TIJUANA, BAJA CALIFORNIA 22680 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22680 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNLOADER ONE |
| Generic Name | ORTHOSIS, LIMB BRACE |
| Product Code | IQI |
| Date Received | 2017-09-28 |
| Returned To Mfg | 2017-08-23 |
| Catalog Number | B-240529713 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OSSUR MEXICO |
| Manufacturer Address | BOULEVARD HECTOR TERAN TERAN 2 EDIFICIO #1 COL. CANON DEL PAD TIJUANA, BAJA CALIFORNIA 22680 MX 22680 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-09-28 |