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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 Date 06/14/2019
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 the patient under nipple-sparing skin-sparing mastectomy, implant and strattice based reconstruction on (b)(6) 2018. This was complicated by moderate amount of perimplant hematoma and seroma that was treated conservatively with serial ultrasound-guided drainage. The situation did not resolve; therefore, there was exploration of the reconstruction, which was performed on friday(b)(6) 2019. The approach was through the site of the previous incision on the inframammary fold where the implant was found to be ruptured. There was the old hematoma and some perimplant seroma as well. Almost all of the strattice was taken, and there was no active bleeding or signs of infection.
 
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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
9089471470
MDR Report Key8793422
MDR Text Key151126210
Report Number1000306051-2019-00096
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K070560
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/16/2019
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 Received08/12/2019
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: 07/16/2019 Patient Sequence Number: 1
Treatment
IMPLANT
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