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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 25, FIRM MESH, SURGICAL

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STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 25, FIRM MESH, SURGICAL Back to Search Results
Catalog Number 2025002
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hernia (2240); Obstruction/Occlusion (2422)
Event Date 10/26/2017
Event Type  Injury  
Event Description
It was reported through a legal event that a 32 year old male patient had hernia repair surgery on or about (b)(6) 2014. During the hernia repair surgery, the surgeon implanted a strattice mesh, lot sp100019-179 and the catalog number is 2025002. After surgery the patient returned to the hospital on or about october 26, 2017 and was diagnosed with recurrent incisional hernia with incarceration of bowel. The patient underwent a laparoscopic robotic extensive lysis of adhesions and incisional hernia repair with placement of additional mesh. Patient's surgeon stated adhesions of the small bowel and noted a serosal injury which was adherent to the significant hernia.
 
Manufacturer Narrative
This legal event is being reported as serious injury due to the reported recurrence with surgical intervention. Internal investigation into strattice lot sp100019 included a review of the reported information, review of the device history records, and a review of the complaint history records. The investigation resulted in no remarkable findings, including no other complaints reported against the lot and no deviations or related non-conformances revealed during processing. The lot was terminally sterilized within the process parameters and met all qc release criteria. As of (b)(6) 2022, of the 197 devices released to finished goods for lot sp100019, 182 have been distributed with 109 reported as implanted. Based on our internal investigation with no remarkable findings, and without relevant patient factors, a relationship between the strattice and this event could not be determined. Due to the legal process, if additional information is made available during legal proceedings, a supplemental report will be submitted.
 
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Brand NameSTRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 25, FIRM
Type of DeviceMESH, SURGICAL
Manufacturer Contact
christopher belle
1 millennium way
branchburg, NJ 08876
9089471470
MDR Report Key15157102
MDR Text Key297154963
Report Number1000306051-2022-00129
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,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 08/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/03/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number2025002
Device Lot NumberSP100019
Was Device Available for Evaluation? No
Date Manufacturer Received07/08/2022
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: 08/03/2022 Patient Sequence Number: 1
Treatment
NO INFORMATION
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