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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIFECELL 10 X 16 PLIABLE STRATTICE FOR EU DISTRIBUTION MESH, SURGICAL

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LIFECELL 10 X 16 PLIABLE STRATTICE FOR EU DISTRIBUTION MESH, SURGICAL Back to Search Results
Catalog Number 1016001EU
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Wound Dehiscence (1154); Hematoma (1884); Post Operative Wound Infection (2446)
Event Date 08/17/2018
Event Type  Injury  
Manufacturer Narrative
(b)(6). This mdr is being reported as serious injury. Although the strattice device was reported to be unaffected, explant surgery was scheduled due to exposure of the strattice and breast implant. The left breast is unaffected. Multiple attempts are being made to gather additional event details, including the strattice lot number and final disposition of the device. The strattice was not returned to lifecell for an evaluation and the lot number remains unknown; therefore an internal investigation into the device history records could not be performed. Based on the information reported, a relationship to strattice was not determined. No further actions are required at this time, as a nonconformance could not be confirmed. If additional information is received, a supplemental report will be submitted.
 
Event Description
It was reported that a female patient underwent skin sparing mastectomy and bilateral pre-pec breast reconstruction with bilateral strattice devices and breast implants on (b)(6) 2018. The patient had developed a hematoma 3 weeks post-operatively to the right breast then subsequently presented with infection and exposure/extrusion of strattice and breast implant to the same side. It was reported that the strattice was unaffected, and there was regression of symptoms and signs following antibiotics; however the strattice and implant will be removed because they were "extruded. " surgery was scheduled for (b)(6) 2018.
 
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Brand Name10 X 16 PLIABLE STRATTICE FOR EU DISTRIBUTION
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 Key7877023
MDR Text Key120294357
Report Number1000306051-2018-00116
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K070560
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/14/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/29/2020
Device Catalogue Number1016001EU
Device Lot NumberSP100615
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 Received09/14/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/15/2018
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: 09/14/2018 Patient Sequence Number: 1
Treatment
BREAST IMPLANTS ((B)(6) 2018 - (B)(6) 2018)
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