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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 25, FIRM MESH, SURGICAL

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STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 25, FIRM MESH, SURGICAL Back to Search Results
Catalog Number 2025002
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hernia (2240)
Event Date 10/05/2018
Event Type  Injury  
Event Description
It was reported to ps by the legal department that a patient underwent hernia repair and implanted with strattice on (b)(6) 2017. There were other revision surgeries on (b)(6)2018 and (b)(6) 2019. No other information was reported. The lot (s) associated with this complaint remains unknown.
 
Manufacturer Narrative
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.
 
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Brand NameSTRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 25, FIRM
Type of DeviceMESH, SURGICAL
Manufacturer Contact
christopher belle
1 millennium way
branchburg, NJ 08876
9089471470
MDR Report Key14346383
MDR Text Key291295789
Report Number1000306051-2022-00086
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 Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 07/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/10/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number2025002
Device Lot NumberSP100443
Was Device Available for Evaluation? No
Date Manufacturer Received07/05/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/10/2022 Patient Sequence Number: 1
Treatment
NO INFORMATION REPORTED
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