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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRATTICE LAPAROSCOPIC 16CM X 20CM MESH, SURGICAL

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STRATTICE LAPAROSCOPIC 16CM X 20CM MESH, SURGICAL Back to Search Results
Catalog Number 1620005
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Hernia (2240)
Event Date 06/08/2020
Event Type  Injury  
Manufacturer Narrative
An investigation into lot sp100288 resulted in no remarkable findings and no processing deviation and no nonconformance's revealed. Lot sp100288 was aseptically processed, terminally sterilized and met all qc release criteria. There were two other unrelated complaints reported for this lot. As of (b)(6) 2021, of the (b)(4) devices released to finished goods for lot sp100288, (b)(4) have been distributed. Of the (b)(4) distributed, (b)(4) have been reported as implanted.
 
Event Description
It was reported that the patient underwent hernia repair surgery at (b)(6) medical center on (b)(6) 2015 and was implanted with strattice. 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 second strattice lot implanted, (b)(4), record 2 of 2.
 
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Brand NameSTRATTICE LAPAROSCOPIC 16CM X 20CM
Type of DeviceMESH, SURGICAL
Manufacturer Contact
christopher belle
1 millennium way
branchburg, NJ 08876
9089471470
MDR Report Key12206409
MDR Text Key276919679
Report Number1000306051-2021-03041
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
Report Date 07/21/2021
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 Number1620005
Device Lot NumberSP100288
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
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