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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TEI BIOSCIENCES INC SURGIMEND 2.0 10X15 CM

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TEI BIOSCIENCES INC SURGIMEND 2.0 10X15 CM Back to Search Results
Catalog Number 606-200-006
Device Problem Use of Device Problem (1670)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/24/2020
Event Type  malfunction  
Manufacturer Narrative
The complaint device is still implanted and will not be returned to the manufacturer for evaluation. The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.
 
Event Description
A health professional reported that on (b)(6) 2020, surgimend (id 606-200-006) was supposed to be used in a robotic case, however they discovered that the mesh was almost 4mm thick which made it very difficult to suture robotically when typically the suture glides right through the mesh. The event led to one hour surgical delay due to product being difficult to suture robotically. No patient adverse consequence due to the product problem.
 
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Brand NameSURGIMEND 2.0 10X15 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
1000 campus drive
princeton, NJ 08536
6099362319
MDR Report Key10279255
MDR Text Key206971449
Report Number3004170064-2020-00003
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 user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/24/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/15/2020
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number606-200-006
Device Lot Number1905038
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 Received04/06/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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