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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
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Hernia (2240); Obstruction/Occlusion (2422)
Date of Event 08/25/2014
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This is a known potential adverse event addressed in the product labeling.
 
Event or Problem 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 Name
STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 25, FIRM
Common Device Name
MESH, SURGICAL
Manufacturer (Section D)
LIFECELL
1 millennium way
branchburg NJ
MDR Report Key11614906
Report Number1000306051-2021-00024
Device Sequence Number16933307
Product Code FTM
UDI-Device Identifier00818410010157
UDI-Public00818410010157
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K070560
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2011
Device Explanted Year2014
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Other
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Catalogue Number2025002
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 03/09/2021
Initial Report FDA Received Date04/05/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age57 YR
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