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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIFECELL STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 25 X 40, FIRM MESH, SURGICAL

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LIFECELL STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 25 X 40, FIRM MESH, SURGICAL Back to Search Results
Catalog Number 2540002
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hernia (2240); Obstruction/Occlusion (2422)
Event Date 01/14/2019
Event Type  Injury  
Manufacturer Narrative
It was reported that a patient underwent a hernia repair with strattice and was later diagnosed with an acute small bowel obstruction with incarcerated hernia requiring removal of the strattice mesh. The internal investigation is pending and will be reported in a follow up report along with the investigation conclusion.
 
Event Description
It was reported that a (b)(6) year old male patient underwent a hernia repair on (b)(6) 2016 at (b)(6) in (b)(6) and was implanted with strattice lot sp100442-201. After the surgery, the patient returned to the hospital on (b)(6) 2019 and was diagnosed with an acute small bowel obstruction with incarcerated hernia requiring removal of the strattice mesh at (b)(6).
 
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Brand NameSTRATTICE RECONSTRUCTIVE TISSUE MATRIX, 25 X 40, 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 Key12124588
MDR Text Key268135363
Report Number1000306051-2021-03013
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,Followup,Followup
Report Date 07/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/06/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number2540002
Device Lot NumberSP100443
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/15/2021
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: 07/06/2021 Patient Sequence Number: 1
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