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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIFECELL MEDIUM CURVED SHAPE FOR STRATTICE, BPS (CONTOUR2) MESH, SURGICAL

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LIFECELL MEDIUM CURVED SHAPE FOR STRATTICE, BPS (CONTOUR2) MESH, SURGICAL Back to Search Results
Catalog Number CON2006
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cellulitis (1768); Seroma (2069)
Event Date 05/29/2020
Event Type  Injury  
Manufacturer Narrative
Based on current information, relationship of this event cannot be determined. The internal investigation into lot # sp200194 included a review of the reported information, review of the complaint history records. There are no other complaints against this lot. Device history review has been requested, and is currently ongoing. Further follow up with the reporting healthcare professional will be conducted to obtain additional patient and event information. It was reported that the device will not be returned for analysis.
 
Event Description
Healthcare professional reported that patient developed heavy seroma out put around the strattice, which resulted in the removal of it. "patient is doing well. ".
 
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Brand NameMEDIUM CURVED SHAPE FOR STRATTICE, BPS (CONTOUR2)
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
brent livingstone
1 millennium way
branchburg, NJ 08876
9089471470
MDR Report Key10251393
MDR Text Key198319013
Report Number1000306051-2020-00032
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
PMA/PMN Number
K082176
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/31/2021
Device Catalogue NumberCON2006
Device Lot NumberSP200194
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 Received06/03/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/17/2020
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: 07/09/2020 Patient Sequence Number: 1
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