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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TEI BIOSCIENCES INC SURGIMEND 3.0 25X40 CM

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TEI BIOSCIENCES INC SURGIMEND 3.0 25X40 CM Back to Search Results
Catalog Number 606-300-016
Device Problem Material Deformation (2976)
Patient Problem Unspecified Gastrointestinal Problem (4491)
Event Date 04/28/2020
Event Type  Injury  
Event Description
A facility reported a revision surgery was performed on (b)(6) 2020 due to bowel injury and it was stated that the mesh (606-300-016 surgimend) become entwined with the patient¿s bowel. It required over 5 hours of surgery to remove. However, the patient continues to have difficulties with bowel movements following the removal.
 
Manufacturer Narrative
The surgimend was not returned for evaluation; therefore, an evaluation of the device could not be performed. Lot number information has been provided; therefore, manufacturing records were reviewed and found no anomalies. 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.
 
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Brand NameSURGIMEND 3.0 25X40 CM
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 Key14552173
MDR Text Key293347155
Report Number3004170064-2022-00003
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
Reporter Occupation
Type of Report Initial
Report Date 05/31/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/31/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/28/2021
Device Catalogue Number606-300-016
Device Lot Number1603038
Was Device Available for Evaluation? No
Date Manufacturer Received05/04/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/06/2016
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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