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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIFECELL UNKNOWN STRATTICE MESH, SURGICAL, POLYMERIC

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LIFECELL UNKNOWN STRATTICE MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number UNK STRATTICE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Capsular Contracture (1761)
Event Date 08/28/2019
Event Type  Injury  
Manufacturer Narrative
The device has not been returned as it remains implanted. 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 the patient was implanted with strattice and a breast implant on (b)(6) 2016. The strattice did not incorporate well and there was capsular contracture baker grade iv. Healthcare professional does not know if the lot number is obtainable for the strattice. Device remains implanted.
 
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Brand NameUNKNOWN STRATTICE
Type of DeviceMESH, SURGICAL, POLYMERIC
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 Key8978135
MDR Text Key157036072
Report Number8020862-2019-00003
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
PMA/PMN Number
K123128
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/09/2019
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?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/28/2019
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: 09/09/2019 Patient Sequence Number: 1
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