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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR TEXAS UNKNOWN

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MENTOR TEXAS UNKNOWN Back to Search Results
Catalog Number UNKNOWN_MENTOR
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Capsular Contracture (1761)
Event Date 12/31/2016
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made. Device history record (dhr) review cannot be conducted because no lot number was provided by the customer. Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.   information regarding patient weight, height, medical history, race, and ethnicity was not reported. Mentor manufacturer's report numbers: 1645337-2020-09934. 1645337-2020-09935. 1645337-2020-09939. 1645337-2020-09942. 1645337-2020-10034. 1645337-2020-10035. 1645337-2020-10036. 1645337-2020-10037. 1645337-2020-10038. Are related to the same incident.
 
Event Description
This complaint is from a literature source. As reported in the literature publication entitled ¿immediate breast reconstruction surgery with expander/direct implant and use of acellular dermal matrix: does hormone therapy increases the risk of infection?¿. 1 patient with breast cancer who underwent expander/implant breast reconstruction experienced from no-hormone therapy group experienced capsular contracture. The purpose of this study was to evaluate hormone therapy and the risk of infection for patients underwent breast reconstruction surgery with expander/direct implant and the use of acellular dermal matrix. Methods. ¿ a prospective study was performed on patients undergoing breast reconstruction at an academic institution from 2013 to 2016. Patients were divided by use of hormone therapy at the time of surgery. Complication rates, including infections, necrosis, seroma and hematomas, were compared and analyzed using univariate and logistic regression models.
 
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Brand NameUNKNOWN
Type of DeviceUNKNOWN
Manufacturer (Section D)
MENTOR TEXAS
3041 skyway circle north
irving TX 75038
Manufacturer (Section G)
MENTOR TEXAS
3041 skyway circle north
irving TX 75038
Manufacturer Contact
gabriel alfageme
3041 skyway circle north
irving, TX 75038
949789-868
MDR Report Key10401782
MDR Text Key202730282
Report Number1645337-2020-09945
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
UNK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation
Type of Report Initial
Report Date 07/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/13/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKNOWN_MENTOR
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/21/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 08/13/2020 Patient Sequence Number: 1
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