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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 Patient-Device Incompatibility (2682)
Patient Problems Hernia (2240); Obstruction/Occlusion (2422)
Event Date 06/28/2018
Event Type  Injury  
Manufacturer Narrative
Qa investigation into lot sp100477 resulted in no remarkable findings and no deviations and no nonconformance revealed. 210 devices were released to finished goods and 139 have been distributed. Of the 139 distributed, 79 have been reported as implanted no other complaints against the lot sp100477 were revealed. Lot sp100477 was aseptically processed, terminally sterilized and met all qc release criteria.
 
Event Description
Patient representative reported a male patient had strattice, 2025002, implanted on (b)(6) 2017 for a ventral hernia repair. Patient was hospitalized on (b)(6) 2018 and a revision surgery took place for a bowel obstruction and hernia revision on b)(6) 2018. Lot number sp100477-004.
 
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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 08876
Manufacturer (Section G)
LIFECELL
1 millennium way
branchburg NJ 08876
Manufacturer Contact
christopher belle
1 millennium way
branchburg, NJ 08876
9089471470
MDR Report Key11968061
MDR Text Key255183791
Report Number1000306051-2021-03004
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 Received06/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number2025002
Device Lot NumberSP100477
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/13/2021
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: 06/09/2021 Patient Sequence Number: 1
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