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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TEI BIOSCIENCES INC SURGIMEND PRS 10CM X 15CM SEMI

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TEI BIOSCIENCES INC SURGIMEND PRS 10CM X 15CM SEMI Back to Search Results
Catalog Number 606-004-100
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Capsular Contracture (1761)
Event Type  Injury  
Manufacturer Narrative
The device is not expected to be returned to the manufacturer for analysis. The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.
 
Event Description
The surgeon reported to sales agent that over the last 6 months he had noticed a few of his breast reconstruction cases have had capsular contracture issues. The surgeon is going to stop using surgimend prs. No additional information will be available.
 
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Brand NameSURGIMEND PRS 10CM X 15CM SEMI
Type of DeviceSURGIMEND
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 Key8784420
MDR Text Key150822363
Report Number3004170064-2019-00010
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
PMA/PMN Number
K171357
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/21/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/12/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number606-004-100
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/13/2019
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

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