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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 10 X 10, FIRM MESH, SURGICAL

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STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 10 X 10, FIRM MESH, SURGICAL Back to Search Results
Catalog Number 1010002
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Hernia (2240)
Event Date 09/13/2019
Event Type  Injury  
Manufacturer Narrative
A investigation into lot s11075 resulted in no remarkable findings and one unrelated processing deviations and one unrelated nonconformance revealed. (b)(4) devices released to finished goods for lot s11075, (b)(4) have been distributed. Of the (b)(4) distributed, (b)(4) have been reported as implanted. No other complaints against lot s11075 were revealed. Lot 11075 was aseptically processed, terminally sterilized and met all qc release criteria.
 
Event Description
Patient representative reported a (b)(6) yo male patient had strattice, 2025002 and 1010002, implanted on (b)(6) 2012 for a hernia repair. Patient had a surgery on (b)(6) 2019 for a bulging re-occurrent hernia and mesh was explanted. Lot number s11050-239 and (b)(4). This mdr for s11075.
 
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Brand NameSTRATTICE RECONSTRUCTIVE TISSUE MATRIX, 10 X 10, FIRM
Type of DeviceMESH, SURGICAL
Manufacturer Contact
christopher belle
1 millennium way
branchburg, NJ 08876
9089471470
MDR Report Key12041795
MDR Text Key257467919
Report Number1000306051-2021-03018
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 Non-Healthcare Professional
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number1010002
Device Lot NumberS11075
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/26/2021
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: 06/22/2021 Patient Sequence Number: 1
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