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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRATTICE PERFORATED 10 X 16 MESH, SURGICAL

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STRATTICE PERFORATED 10 X 16 MESH, SURGICAL Back to Search Results
Catalog Number 1016002P
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bacterial Infection (1735); Hernia (2240)
Event Date 05/26/2020
Event Type  Injury  
Event Description
Limited information was reported through a legal event that a (b)(6) male underwent hernia repair on or about (b)(6) 2019. During the patient¿s surgery, the surgeon implanted him with strattice, lot number (b)(4) (sku 1016002p). After surgery, the patient returned to the hospital on or about (b)(6) 2020 and was diagnosed with recurrent ventral incisional hernia and chronic mesh infection. The (b)(6) 2020, procedure was a robotic laparoscopic repair left and right myofascial cutaneous release, right transverse abdominis release, lysis of adhesions, wound exploration, and debridement of abdominal wall and placement of additional mesh. No other information was reported.
 
Manufacturer Narrative
This legal event is being reported as serious injury due to the reported recurrence with surgical intervention. Internal investigation into strattice lot sp200019 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. (b)(4). 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 10 X 16
Type of DeviceMESH, SURGICAL
Manufacturer Contact
christopher belle
1 millennium way
branchburg, NJ 08876
9089471470
MDR Report Key14435323
MDR Text Key292029380
Report Number1000306051-2022-00096
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 Number1016002P
Device Lot NumberSP200019
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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