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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TEI BIOSCIENCES INC SURGIMEND MP 13 CM X 25 CM X 2MM

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TEI BIOSCIENCES INC SURGIMEND MP 13 CM X 25 CM X 2MM Back to Search Results
Catalog Number 606-206-003
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bacterial Infection (1735); Necrosis (1971)
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 facility reported a (b)(6) female patient with history of mid-abdominal and right lateral ventral hernia repair with plastic surgery reconstruction ((b)(6) 2021) developed an abdominal infection. The surgeon believe that the patient did not have a graft infection, but she developed necrosis of her abdominal wall at first week follow up after the surgery. She was treated by plastic surgery on (b)(6) 2021. On (b)(6) 2021, a bacterial culture was taken and showed positive for infection. The patient was treated with antibiotics. Product was not removed.
 
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Brand NameSURGIMEND MP 13 CM X 25 CM X 2MM
Type of DeviceSURGIMEND
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 Key12800270
MDR Text Key282227682
Report Number3004170064-2021-00012
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
PMA/PMN Number
K162965
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/06/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number606-206-003
Device Lot Number2006008
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received05/02/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/03/2020
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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