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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIFECELL STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 10 X 10, FIRM MESH, SURGICAL

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LIFECELL STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 10 X 10, FIRM MESH, SURGICAL Back to Search Results
Catalog Number 1010002
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Cellulitis (1768)
Event Date 03/19/2018
Event Type  Injury  
Manufacturer Narrative
Our investigation of lot sp100543 includes: manufacturing review: review of information as reported, review of the device history records and complaint history records associated with lot sp100543. Results of evaluation: no failure detected. Review of the lot processing history and the complaint history records for lot sp100543 was unremarkable. There were no processing deviations or nonconformance related to the nature of this complaint. The lot met qc criteria for release, including mechanical testing results. As of 27 mar 2018, no other complaint has been reported to lifecell against lot sp100543. As of 27 mar 2018, of the (b)(4) devices released to finished goods for lot sp100543, all (b)(4) devices were distributed with 85 devices reported to be implanted. Based on our internal review of the device processing history, the lot met qc criteria for product release. Lot sp100543 was aseptically processed, terminally sterilized within process parameters, and met qc release criteria. No deviation was encountered in association with the reported event. No other complaint has been reported to lifecell against lot sp100543.
 
Event Description
It was reported that due to incarcerated inguinal hernia, the female patient underwent ventral hernia repair with strattice on (b)(6) 2018. The patient presented with postoperative cellulitis. The cause of the cellulitis is unknown as the surgeon is unsure if the reaction is related to the strattice. Surgical intervention to remove the strattice mesh was scheduled but a date was not provided.
 
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Brand NameSTRATTICE RECONSTRUCTIVE TISSUE MATRIX, 10 X 10, 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 Key7432666
MDR Text Key105542206
Report Number1000306051-2018-00048
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
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
Report Date 04/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/16/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/31/2019
Device Catalogue Number1010002
Device Lot NumberSP100543
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 Received03/19/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/30/2017
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: 04/16/2018 Patient Sequence Number: 1
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