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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 Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problem Insufficient Information (4580)
Event Date 10/23/2014
Event Type  Injury  
Manufacturer Narrative
This event is being reported in an abundance of caution as serious injury due to the report of device explant. The lot associated with this event was not reported and remains unknown; therefore a review of the device history records could not be performed. No strattice devices were returned for evaluation. Based on the limited information reported, a relationship between the event and strattice could not be determined. Due to the legal process, if additional information is made available during legal proceedings, the information will be sent to product surveillance for further evaluation. To date, no additional information has been received. No further actions are required, a nonconformance was not confirmed.
 
Event Description
It was reported through a legal event that a 59 year old patient had hernia repair surgery on or about (b)(6) 2013. During the hernia repair surgery, the surgeon implanted a strattice firm mesh. After surgery, the patient had a removal surgery on (b)(6) 2014.
 
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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 Key14704605
MDR Text Key294125319
Report Number1000306051-2022-00108
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 10/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/15/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number1010002
Device Lot NumberS11176
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received10/09/2022
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: 06/15/2022 Patient Sequence Number: 1
Treatment
NO INFORMATION REPORTED
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