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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 Seroma (2069)
Event Type  Injury  
Manufacturer Narrative
The device has not been returned. Based on the information reported, including no identification of the relevant lot number, a relationship between the event and strattice cannot be determined. Strattice as a contributing factor cannot be ruled out. Multiple attempts were made to gather additional information; however to date, no further information has been obtained. The device was not returned for evaluation and the lot number remains unknown; therefore internal investigation into the event could not be performed. If additional information is reported, a follow up adverse event report will be submitted. No further actions are required as a nonconformance could not be confirmed.
 
Event Description
It was reported that a hernia patient had both a strattice and a synthetic mesh placed on (b)(6) 2018 recently had a recurrent seroma. First surgery the doctor placed strattice underlay and placed synthetic mesh overlay. Patient then developed a 1 liter seroma, so doctor took patient back to surgery to re-operate, removed only the synthetic mesh and saw that strattice was incorporated, so the strattice was not removed. Patient now has developed what they call a chronic seroma recurrence.
 
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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 Key8752983
MDR Text Key149786074
Report Number1000306051-2019-00094
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
PMA/PMN Number
K070560
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/02/2019
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 Received06/06/2019
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: 07/02/2019 Patient Sequence Number: 1
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