MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-29 for T-SCOPE PREMIER 08814 manufactured by Breg, Inc..
[87861712]
Product received and evaluated on 9/28/2017. Product was found to be altered as two holes had been drilled in both telescoping bars, otherwise product was found to meet all requirements with no evidence of malfunction.
Patient Sequence No: 1, Text Type: N, H10
[87861713]
Breg received a report of a tscope brace rubbing over/above the patella resulting in a re-rupturing of the quadricept tendon.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2028253-2017-00076 |
| MDR Report Key | 6906445 |
| Date Received | 2017-09-29 |
| Date of Report | 2017-09-29 |
| Date Mfgr Received | 2017-08-03 |
| Date Added to Maude | 2017-09-29 |
| 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. CAROL EMERSON |
| Manufacturer Street | 2885 LOKER AVENUE EAST |
| Manufacturer City | CARLSBAD CA 92010 |
| Manufacturer Country | US |
| Manufacturer Postal | 92010 |
| Manufacturer Phone | 7607955823 |
| Manufacturer G1 | BREG, INC. |
| Manufacturer Street | 2885 LOKER AVENUE EAST |
| Manufacturer City | CARLSBAD CA 92010 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92010 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | T-SCOPE PREMIER |
| Generic Name | T-SCOPE PREMIER |
| Product Code | IQI |
| Date Received | 2017-09-29 |
| Returned To Mfg | 2017-09-28 |
| Model Number | 08814 |
| Catalog Number | 08814 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BREG, INC. |
| Manufacturer Address | 2885 LOKER AVENUE EAST CARLSBAD CA 92010 US 92010 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-09-29 |