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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 6 X 16, FIRM; MESH, SURGICAL
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STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 6 X 16, FIRM; MESH, SURGICAL Back to Search Results
Catalog Number 0616002
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Hernia (2240)
Event Date 08/22/2017
Event Type  Injury  
Manufacturer Narrative
A investigation into lot s10731 resulted in no remarkable findings with there were 2 unrelated processing deviations and no nonconformances to the nature of this complaint.As of 7/22/21, of the 185 devices released to finished goods for lot s10731, 154 have been distributed.Of the 154 distributed, 78 have been reported as implanted.Also, two other unrelated complaints.
 
Event Description
It was reported that a (b)(6) year old patient underwent a primary umbilical hernia repair surgery on (b)(6) 2010 and was implanted with strattice lot s10731-089.Seven year later, the patient returned to the hospital on or about (b)(6) 2017 and was diagnosed with a large reducible ventral hernia.On or about (b)(6) 2017 the patient had an unincorporated mesh removal.
 
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Brand Name
STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 6 X 16, FIRM
Type of Device
MESH, SURGICAL
Manufacturer Contact
christopher belle
1 millennium way
branchburg, NJ 08876
9089471470
MDR Report Key12213100
MDR Text Key267876666
Report Number1000306051-2021-03044
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K070560
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Other
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number0616002
Device Lot NumberS10731
Was Device Available for Evaluation? No
Date Manufacturer Received07/01/2021
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 Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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