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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIFECELL STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 25, FIRM MESH, SURGICAL

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LIFECELL STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 25, FIRM MESH, SURGICAL Back to Search Results
Catalog Number 2025002
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hernia (2240); Obstruction/Occlusion (2422)
Event Date 08/25/2014
Event Type  Injury  
Manufacturer Narrative
This is a known potential adverse event addressed in the product labeling.
 
Event Description
Patient underwent primary ventral incisional hernia repair surgery and stattice mesh implanted. Patient returned to the hospital 3 years later and was diagnosed with partial small-bowel obstruction and a recurrent ventral incisional hernia with incarceration. Mesh removed.
 
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Brand NameSTRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 25, FIRM
Type of DeviceMESH, SURGICAL
Manufacturer (Section D)
LIFECELL
1 millennium way
branchburg NJ
Manufacturer (Section G)
LIFECELL
1 millennium way
branchburg NJ
Manufacturer Contact
christopher belle
1 millennium way
branchburg, NJ 
9089471470
MDR Report Key11614906
MDR Text Key243806637
Report Number1000306051-2021-00024
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
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/05/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number2025002
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/09/2021
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 Treatment Data
Date Received: 04/05/2021 Patient Sequence Number: 1
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