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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIFECELL STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 30, FIRM; MESH, SURGICAL
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LIFECELL STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 30, FIRM; MESH, SURGICAL Back to Search Results
Catalog Number 2030002
Device Problem Patient Device Interaction Problem (4001)
Patient Problem Abscess (1690)
Event Date 02/14/2018
Event Type  Injury  
Manufacturer Narrative
The event is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.Qa investigation is pending at this time.A supplemental medwatch will be submitted upon completion of device history review.
 
Event Description
Legal affairs reports patient underwent incisional hernia repair surgery.Strattice mesh implanted.Patient returned to hospital 1.5 years later because of abdominal wall abscess and unincorporated mesh requiring removal of the mesh.Mesh removed.
 
Manufacturer Narrative
Qa investigation into lot sp100331 resulted in no remarkable findings and no deviations and no nonconformances revealed.181 devices were released to finished goods and 168 have been distributed.Of the 168 distributed, 80 have been reported as implanted.Lot sp100331 was terminally sterilized and met all qc release criteria including mechanical testing.
 
Event Description
Legal affairs reports patient underwent incisional hernia repair surgery.Strattice mesh implanted.Patient returned to hospital 1.5 years later because of abdominal wall abscess and unincorporated mesh requiring removal of the mesh.Mesh removed.
 
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Brand Name
STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 30, FIRM
Type of Device
MESH, SURGICAL
Manufacturer (Section D)
LIFECELL
1 millennium way
branchburg NJ
MDR Report Key11427070
MDR Text Key246843156
Report Number1000306051-2021-00017
Device Sequence Number1
Product Code FTM
UDI-Device Identifier00818410010393
UDI-Public00818410010393
Combination Product (y/n)N
PMA/PMN Number
K070560
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date11/30/2017
Device Catalogue Number2030002
Device Lot NumberSP100331
Was Device Available for Evaluation? No
Date Manufacturer Received04/08/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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