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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TEI BIOSCIENCES INC SURGIMEND MATRIX - UNSPECIFIED N/A

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TEI BIOSCIENCES INC SURGIMEND MATRIX - UNSPECIFIED N/A Back to Search Results
Catalog Number XXX-SURGIMEND
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hematoma (1884); Unspecified Infection (1930); Injury (2348)
Event Type  Injury  
Manufacturer Narrative
The device involved in the reported incident is not available for evaluation. An investigation has been initiated based on the reported information.
 
Event Description
In vivo published (2017) "a head to head comparison between surgimend ¿fetal bovine acellular dermal matrix and tutomesh ¿a bovine pericardium collagen membrane in breast reconstruction in 45 cases". Method: this is a retrospective analysis of a 2-year experience with both surgimend - fetal bovine acellular dermal matrix and tutomesh - a bovine pericardium collagen membrane in breast reconstruction in 45 cases from 2014-2015. Complications noticed for surgimend: three (3) post operative redness (overall postoperative redness - no intervention required); three (3) red breast syndrome; one (1) infection requiring i. V. Antibiotics; one (1) hematoma; four (4) subsequent revision surgery (revision surgery due to capsular contracture, tumor recurrence etc. [more than 6 months post op]). Results: forty-five patients received a total of 45 implant-based reconstructions using surgimend (18 cases; 40%) or tutomesh (27 cases; 60%). Gross complication rates were 27. 8% for surgimend and 37. 0% for tutomesh including hematoma, postoperative skin irritation, infection, red breast syndrome and revision surgery. The most common complication was postoperative red breast syndrome. Conclusion: this retrospective analysis shows similar overall clinical complication rates for tutomesh and surgimend. It is the only head-to head comparison of tutomesh in breast surgery available today. Severe complication rates are comparable to those reported in literature for both products. Although the retrospective nature and limited numbers of this work limits its clinical impact, tutomesh offers a viable and cost effective option in adm supported breast reconstruction.
 
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Brand NameSURGIMEND MATRIX - UNSPECIFIED
Type of DeviceN/A
Manufacturer (Section D)
TEI BIOSCIENCES INC
7 elkins street
7 elkins street
boston MA 02127
Manufacturer (Section G)
TEI BIOSCIENCES INC
7 elkins street
boston MA 02127
Manufacturer Contact
vivian nelson
311 enterprise drive
plainsboro, NJ 08536
6099362393
MDR Report Key8214679
MDR Text Key132050267
Report Number3004170064-2019-00002
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
PMA/PMN Number
K083898
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/20/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/03/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberXXX-SURGIMEND
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 Received01/18/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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