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

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.

Manufacturer Narrative

Surgimend was not returned for evaluation and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and manufacturing records could not be reviewed.The cause(s) of the difficulty reported by the customer could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

Event Description

N/a.

• Brand Name: SURGIMEND MATRIX - UNSPECIFIED
• Type of Device: N/A
• Manufacturer (Section D): TEI BIOSCIENCES INC; 7 elkins street; 7 elkins street; boston MA
• MDR Report Key: 11547549
• MDR Text Key: 251417945
• Report Number: 3004170064-2021-00003
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• PMA/PMN Number: K071807
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 03/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: XXX-SURGIMEND
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/25/2021
• Initial Date FDA Received: 03/22/2021
• Supplement Dates Manufacturer Received: 03/25/2021
• Supplement Dates FDA Received: 03/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1