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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNKNOWN STRATTICE MESH, SURGICAL

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UNKNOWN STRATTICE MESH, SURGICAL Back to Search Results
Catalog Number UNK STRATTICE
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Bacterial Infection (1735); Hernia (2240)
Event Type  Injury  
Manufacturer Narrative
The lot number(s) associated with this event remains unknown; therefore an internal investigation could not be performed. If additional information is received, a follow up report will be submitted within 30 calendar days. Without identification of the lot numbers(s), a relationship to the strattice was not determined. This report concludes our investigation at this time.
 
Event Description
This literature review is a 5 year follow up analysis on absorbable biologic mesh for complex abdominal wall reconstruction. This is a review of the longevity of those repairs comparing p4hb and porcine cadaveric mesh.
 
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Brand NameUNKNOWN STRATTICE
Type of DeviceMESH, SURGICAL
Manufacturer Contact
christopher belle
1 millennium way
branchburg, NJ 08876
9089471470
MDR Report Key12199096
MDR Text Key267246782
Report Number1000306051-2021-03045
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 literature
Reporter Occupation
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK STRATTICE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/06/2021
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: 07/20/2021 Patient Sequence Number: 1
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