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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 10 X 10, FIRM MESH, SURGICAL

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STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 10 X 10, FIRM MESH, SURGICAL Back to Search Results
Catalog Number 1010002
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hernia (2240)
Event Date 06/03/2021
Event Type  Injury  
Manufacturer Narrative
Internal investigation into strattice lot sp200172 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 136 devices released to finished goods for lot sp200019, 132 have been distributed with 78 reported as implanted. 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.
 
Event Description
It was reported through a legal event that a (b)(6) female patient underwent open repair of ventral/incisional hernia repair surgery on or about (b)(6) 2020. During the hernia repair surgery, the surgeon implanted a strattice firm mesh, item 1010002, lot sp200172 in her. After surgery, the patient returned to the hospital on or about (b)(6) 2021 and was diagnosed with a recurrent ventral hernia. On or about (b)(6) 2021, she underwent open repair of recurrent ventral/incisional hernia with mesh and left and right myocutaneous muscle release for component separation.
 
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Brand NameSTRATTICE RECONSTRUCTIVE TISSUE MATRIX, 10 X 10, FIRM
Type of DeviceMESH, SURGICAL
Manufacturer Contact
christopher belle
1 millennium way
branchburg, NJ 08876
9089471470
MDR Report Key14437850
MDR Text Key292048488
Report Number1000306051-2022-00094
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,Followup,Followup
Report Date 07/06/2022
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 Expiration Date10/31/2021
Device Catalogue Number1010002
Device Lot NumberSP200172
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? 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: 05/19/2022 Patient Sequence Number: 1
Treatment
NO INFORMATION REPORTED
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