MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2019-03-08 for CTI B-238600114 manufactured by Ossur Mexico.
[138211753]
Patient claims the brace should have protected him against injury while performing training on a wakeboard. The ifu of the brace indicates the following: "warning: this device is a supportive brace only, and is not intended or guaranteed to prevent knee injury. " the brace has not been returned for further analysis. Without the brace (or pictures) it cannot be determined whether the brace has malfunctioned during use.
Patient Sequence No: 1, Text Type: N, H10
[138211754]
Patient got injured during wakeboarding training and his left acl was torn.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008523132-2019-00001 |
| MDR Report Key | 8403230 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2019-03-08 |
| Date of Report | 2019-03-08 |
| Date of Event | 2018-09-16 |
| Date Mfgr Received | 2019-02-13 |
| Date Added to Maude | 2019-03-08 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KATLA AXELSDOTTIR |
| Manufacturer Street | GRJOTHALS 1-5 |
| Manufacturer City | REYKJAVIK 110 |
| Manufacturer Country | IC |
| Manufacturer Postal | 110 |
| Single Use | 3 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CTI |
| Generic Name | KNEE BRACE |
| Product Code | IQI |
| Date Received | 2019-03-08 |
| Model Number | B-238600114 |
| Catalog Number | B-238600114 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OSSUR MEXICO |
| Manufacturer Address | BLVD. HECTOR TERAN TERAN 2102 BUILD.#1 COL. CANON DEL PADRE TIJUANA, BAJA CALIFORNIA 22206 MX 22206 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-03-08 |