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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 Problems Device Appears to Trigger Rejection (1524); Patient Device Interaction Problem (4001)
Patient Problem Injury (2348)
Event Date 09/25/2018
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
It was reported that on (b)(6) 2018, a surgimend matrix was used for a breast reconstruction case. It was noted that there were no incorporation of the product and the patient had implant exposure 3 months post-op. Bilateral procedure had to be conducted to address the issue. Additional information has been requested.
 
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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
6099362319
MDR Report Key7980943
MDR Text Key124318925
Report Number3004170064-2018-00007
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 company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 09/25/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/18/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number606-004-100
Device Lot Number1602023
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 Received08/26/2019
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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