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

MAUDE Adverse Event Report: STRATTICE LAPAROSCOPIC 20CM X 20CM 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 LAPAROSCOPIC 20CM X 20CM MESH, SURGICAL Back to Search Results
Catalog Number 2020005
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Hernia (2240)
Event Date 04/13/2016
Event Type  Injury  
Manufacturer Narrative
An investigation into lot sp100148 resulted in no remarkable findings with one unrelated processing deviation and one unrelated nonconformance's revealed. Lot sp100148 was aseptically processed, terminally sterilized and met all qc release criteria. No other complaints reported for this lot. As of 7/20/2021, of the (b)(4) devices released to finished goods for lot sp100148, (b)(4) have been distributed. Of the (b)(4) distributed, 130 have been reported as implanted.
 
Event Description
Patient representative reported that the patient underwent hernia repair surgery at ochsner medical center on (b)(6) 2015 and was implanted with strattice lot (b)(4). The patient returned to the hospital on (b)(6) 2016 for further surgery because the strattice device failed by not adhering to the patient's abdominal wall and allowing a hernia recurrence. The patient's strattice was not removed during this procedure and instead another strattice lot was placed, (b)(4). The patient returned to the hospital on (b)(6) 2020 because the strattice mesh failed again. Among other things, it contracted, failed to adhere to the patient's abdominal wall, wadded up, and allowed the patient's bowel to hernia through the mesh repair. The patient required surgery to remove the strattice and repair the defect. This record is associated with the first strattice lot implanted, (b)(4), record 1 of 2.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSTRATTICE LAPAROSCOPIC 20CM X 20CM
Type of DeviceMESH, SURGICAL
Manufacturer Contact
christopher belle
1 millennium way
branchburg, NJ 08876
9089471470
MDR Report Key12206566
MDR Text Key264861863
Report Number1000306051-2021-03040
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130817
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/21/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number2020005
Device Lot NumberSP100148
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/30/2021
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: 07/21/2021 Patient Sequence Number: 1
-
-