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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 Migration or Expulsion of Device (1395)
Patient Problem Obstruction/Occlusion (2422)
Event Date 05/01/2020
Event Type  Injury  
Manufacturer Narrative
An investigation has been initiated based on the reported information. Upon completion of the investigation, a follow-up report will be submitted.
 
Event Description
A patient reported a surgimend mesh migration: on (b)(6), 2020, the patient fell gravely ill, was rushed to the hospital and approximately 6 days later went into surgery due to mesh migration and a subsequent bowel obstruction in addition to other difficulties. The mesh migrated throughout the intestines. The mesh was removed, and no other mesh was placed, and spent eleven days recovering at the hospital. Throughout the course of those eleven days, the patient was subject to multiple tests, no painkillers, bone drills and so forth. Outcome as reported by the patient: ¿the outcome was that part of my intestine was removed thus causing a deteriorated quality of life. I have not been able to seek out work or otherwise because of my condition. I cannot live my day to day life without having to go to the bathroom constantly and i am even subject to losing complete control of my bowels due to the subsequent obstruction caused by the mesh. The mesh migrating and failing has been a huge hit to my health and well-being and has overall caused immense physical and mental deteriorations.
 
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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
Manufacturer (Section G)
TEI BIOSCIENCES INC
7 elkins street
boston MA
Manufacturer Contact
vivian nelson
1100 campus drive
princeton, NJ 
6099362319
MDR Report Key11547549
MDR Text Key251417945
Report Number3004170064-2021-00003
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
PMA/PMN Number
K071807
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/26/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/22/2021
Is this an Adverse Event Report? No
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? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/25/2021
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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