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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BREG, INC. T-SCOPE PREMIER
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BREG, INC. T-SCOPE PREMIER Back to Search Results
Model Number 08814
Device Problem Insufficient Information (3190)
Patient Problem Rupture (2208)
Event Type  Injury  
Manufacturer Narrative
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.
 
Event Description
Breg received a report of a tscope brace rubbing over/above the patella resulting in a re-rupturing of the quadricept tendon.
 
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Brand Name
T-SCOPE PREMIER
Type of Device
T-SCOPE PREMIER
Manufacturer (Section D)
BREG, INC.
2885 loker avenue east
carlsbad CA 92010
Manufacturer (Section G)
BREG, INC.
2885 loker avenue east
carlsbad CA 92010
Manufacturer Contact
carol emerson
2885 loker avenue east
carlsbad, CA 92010
7607955823
MDR Report Key6906445
MDR Text Key87861712
Report Number2028253-2017-00076
Device Sequence Number1
Product Code IQI
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial
Report Date 09/29/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number08814
Device Catalogue Number08814
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/28/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/03/2017
Initial Date FDA Received09/29/2017
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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