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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIFECELL UNKNOWN STRATTICE MESH, SURGICAL

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LIFECELL UNKNOWN STRATTICE MESH, SURGICAL Back to Search Results
Catalog Number UNK STRATTICE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Death (1802)
Event Type  Death  
Manufacturer Narrative
Conclusion: upon review of the article received, there is one death event listed in the randomization table for biological mesh at the end of the article but not in the results section or in complication data. We do not know if this death event is outside the study or if the patient completed the study. The device has not been returned to allergan for evaluation. Based on limited information, a relationship between the event and the strattice could not be determined. Due to lack of information, strattice as a contributing factor cannot be ruled out. Lifecell reports the event in abundance of caution. Multiple attempts to obtain additional information are being made; however to date, no further information has been obtained. Article citation: ¿preventing recurrence in clean and contaminated hernias (price): a randomized trial of biologic versus synthetic mesh in ventral hernia repair¿, hobart w. Harris, md, et. Al.
 
Event Description
During a literature review of a study manuscript titled ¿preventing recurrence in clean and contaminated hernias (price): a randomized trial of biologic versus synthetic mesh in ventral hernia repair¿ by hobart w. Harris, md, et. Al. , was identified which reported hernia repairs for 163 patients operated on by one of eight surgeons participating in the study. Of these patients , 81 were implanted with strattice. Following implantation surgery for hernia repair, one death was documented, the cause of which was not stated. As it is unknown which patients experienced which events, this record has been created to capture the event of death. The affected location was not specified for the patients; therefore, the location will be captured as unknown. The overall conclusion reported that use of biologic mesh rather than synthetic mesh to repair potentially contaminated or contaminated ventral hernias increases the risk of hernia recurrence without a reduction in postoperative complications.
 
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Brand NameUNKNOWN STRATTICE
Type of DeviceMESH, SURGICAL
Manufacturer (Section D)
LIFECELL
1 millennium way
branchburg NJ 08876
Manufacturer (Section G)
LIFECELL
1 millennium way
branchburg NJ 08876
Manufacturer Contact
christopher belle
1 millennium way
branchburg, NJ 08876
9089471100
MDR Report Key8239484
MDR Text Key132778954
Report Number1000306051-2019-00004
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
Reporter Occupation
Type of Report Initial
Report Date 01/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/11/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK STRATTICE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/12/2018
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: 01/11/2019 Patient Sequence Number: 1
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