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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIFECELL STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 30, FIRM MESH, SURGICAL

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LIFECELL STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 30, FIRM MESH, SURGICAL Back to Search Results
Catalog Number 2030002
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Fistula (1862); Unspecified Infection (1930)
Event Date 07/24/2018
Event Type  Injury  
Manufacturer Narrative
This mdr is being reported in an abundance of caution due to the planned surgical intervention. To date, it is unknown if the device was explanted. Internal investigation into strattice lot sp100588 included a review of the reported information, review of the device history records, and a review of the complaint history records with no remarkable findings, including no other complaints reported against the lot and no related deviations or non-conformances revealed during processing. The lot was aseptically processed, terminally sterilized within the process parameters and met all qc release criteria. As of (b)(6) 2018, of the (b)(4) devices released to finished goods, (b)(4) have been distributed with (b)(4) devices reported as implanted. Based on the results of the investigation with no remarkable findings, a relationship between the strattice and this event could not be determined. No further actions are required as a nonconformance could not be confirmed. If additional information is reported, a supplemental report will be submitted.
 
Event Description
It was reported that a patient underwent abdominal wall reconstruction with strattice, enterolysis and "encolostomy" takedown for a large ventral abdominal wall hernia on (b)(6) 2018. No fascia approximation was achieved and the strattice was placed in underlay fashion and fixed to the posterior and anterior fascia. The operative report also indicates space as "clean contaminated. " subsequently, the patient presents with a possible infection. Explant surgery was scheduled for (b)(6) 2018 with possible device removal.
 
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Brand NameSTRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 30, FIRM
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 Key7991751
MDR Text Key124602358
Report Number1000306051-2018-00132
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,Followup
Report Date 11/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/22/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/31/2019
Device Catalogue Number2030002
Device Lot NumberSP100588
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 Received10/24/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/09/2017
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: 10/22/2018 Patient Sequence Number: 1
Treatment
NO INFORMATION
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