• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 20, FIRM MESH, SURGICAL

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 20, FIRM MESH, SURGICAL Back to Search Results
Catalog Number 2020002
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Hernia (2240); Insufficient Information (4580)
Event Date 08/19/2016
Event Type  Injury  
Manufacturer Narrative
No lot information provided. If additional information is received a follow up will be submitted.
 
Event Description
Patient representative reported patient had strattice, implanted on (b)(6) 2015 for a hernia repair. Strattice was explanted on (b)(6) 2016. Lot number remains unknown.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSTRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 20, FIRM
Type of DeviceMESH, SURGICAL
Manufacturer Contact
christopher belle
1 millennium way
branchburg, NJ 08876
9089471470
MDR Report Key12041796
MDR Text Key257488846
Report Number1000306051-2021-03019
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,Followup
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 Number2020002
Device Lot NumberSP100194
Was Device Available for Evaluation? No
Date Manufacturer Received04/12/2022
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
-
-