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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 30, FIRM MESH, SURGICAL

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STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 30, FIRM MESH, SURGICAL Back to Search Results
Catalog Number 2030002
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hernia (2240)
Event Date 03/11/2021
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) 2016. During the hernia repair surgery, the surgeon implanted a strattice reconstructive tissue matrix item 2030002, lot sp100368 mesh in him. After surgery, 5 years later, the patient had a revision surgery on (b)(6) 2021.
 
Manufacturer Narrative
Internal investigation into strattice lot sp100368 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-conformance's revealed during processing. The lot was terminally sterilized within the process parameters and met all qc release criteria. (b)(4). Based on our internal review with no remarkable findings, a relationship between the strattice and this event could not be determined. No further actions are required as a nonconformance could not be confirmed.
 
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Brand NameSTRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 30, FIRM
Type of DeviceMESH, SURGICAL
Manufacturer Contact
christopher belle
1 millennium way
branchburg, NJ 08876
9089471470
MDR Report Key14457481
MDR Text Key292193300
Report Number1000306051-2022-00095
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 05/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/20/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number2030002
Device Lot NumberSP100368
Was Device Available for Evaluation? No
Date Manufacturer Received04/26/2022
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: 05/20/2022 Patient Sequence Number: 1
Treatment
NO INFORMATION REPORTED
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