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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TEI BIOSCIENCES INC SURGIMEND 2.0 25X40 CM

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TEI BIOSCIENCES INC SURGIMEND 2.0 25X40 CM Back to Search Results
Catalog Number 606-200-016
Device Problem Material Split, Cut or Torn (4008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
To date the device involved in the reported incident has not been received for evaluation. 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 physician reported the surgimend was used for an abr (abdominal wall reconstruction), it was hydrated in heated saline with bacitracin, for about 3-5 min then placed in patient. The surgimend was placed in abdominal cavity and began surgical procedure and approximately 45 minutes later, as surgeons were finishing up placing mesh, mesh started tearing. The procedure was substantially longer as a result of the mesh tearing, somewhere in the 1. 5 to 2 hour range, as it had to be removed and replaced with a new piece. Because it was discovered prior to completing the case, we were able to replace the mesh without any adverse outcome to the patient.
 
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Brand NameSURGIMEND 2.0 25X40 CM
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
105 morgan lane
plainsboro, NJ 08536
6099362319
MDR Report Key10785955
MDR Text Key214580320
Report Number3004170064-2020-00010
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
Report Date 03/29/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/04/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number606-200-016
Device Lot Number1903026
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/19/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/29/2021
Was Device Evaluated by Manufacturer? Yes
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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