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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRATTICE PERFORATED 20 X 30 MESH, SURGICAL

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STRATTICE PERFORATED 20 X 30 MESH, SURGICAL Back to Search Results
Catalog Number 2030002P
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erosion (1750); Seroma (2069); Hernia (2240)
Event Date 08/27/2020
Event Type  Injury  
Event Description
It was reported through a legal event that a (b)(6) male patient underwent hernia repair surgery on or about (b)(6) 2019. During the patient¿s surgery, the surgeon implanted him with strattice lot sp100606 (sku 2030002). After surgery, the patient returned to the hospital on or about (b)(6) 2020, and was diagnosed with recurrent ventral incisional hernia, adhesions, chronic seroma, and small bowl lining deterioration due to mesh. On or about (b)(6) 2020, the patient underwent lysis of adhesions and hernia repair. During this revision surgery, the surgeon noted intra-abdominal adhesions involving the small bowel, omentum, transvest colon, anterior abdominal wall, and previously placed mesh. The surgeon also noted that the graft appeared folded on itself and bunched up along the fascial defect. Multiple loops of small bowel were noted to be decently adherent mesh with serosal erosion and a seroma anterior to the previously placed mesh. It should be the noted the lot number was provided without the serial number and the item number that correlates is 2030002p.
 
Manufacturer Narrative
This legal event is being reported as serious injury due to the reported recurrence with surgical intervention. Internal investigation into strattice lot sp100606 included a review of the reported information, review of the device history records, and a review of the complaint history records with no remarkable findings, including no other complaints reported against the lot and no deviations or non-conformances revealed during processing. The lot was aseptically processed, terminally sterilized within the process parameters, and met all qc release criteria. To date, of the (b)(4) devices released to finished goods, (b)(4) have been distributed with (b)(4) devices reported as implanted. 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 PERFORATED 20 X 30
Type of DeviceMESH, SURGICAL
Manufacturer Contact
christopher belle
1 millennium way
branchburg, NJ 08876
9089471470
MDR Report Key14435248
MDR Text Key292048867
Report Number1000306051-2022-00091
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K150712
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 05/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/19/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number2030002P
Device Lot NumberSP100606
Was Device Available for Evaluation? No
Date Manufacturer Received04/22/2022
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: 05/19/2022 Patient Sequence Number: 1
Treatment
NO INFORMATION REPORTED.
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