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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 Problems Abscess (1690); Post Operative Wound Infection (2446)
Event Type  Injury  
Manufacturer Narrative
Ref corresponding author and institution. This literature review is being reported as an individual event type as serious injury due to the medical intervention to treat the complications of abscess and infection. As per the article, none of the strattice devices had to be removed; therefore, no devices were returned for evaluation. Multiple attempts are being made to gather additional patient and procedure specific information including lot numbers. To date, the lot numbers associated with these events remain unknown; therefore, an internal investigation into the device history records could not be performed. A relationship to the strattice could not be determined. As per the ifu, potential adverse events are those typically associated with surgical mesh materials and/or their implantation procedures including, but not limited to, infection. If additional information is received, a follow up report will be submitted. No further actions are required as a nonconformance could not be confirmed.
 
Event Description
During a literature review, an article titled "simultaneous stoma reinforcement and perineal reconstruction with biological mesh - a multicentre prospective observational study" was identified which reported a non-comparative study of consecutive patients undergoing extralevator abdominoperineal excision (elape) for low rectal cancer and simultaneous perineal reconstruction and colostomy site reinforcement with strattice¿ mesh to assess prevention of hernia formation. A total of 19 patients (11 males, 8 females) were entered into the study. Results reported that 3 patients had a parastomal hernia detected radiologically, 1 patient had pre-sacral abscess requiring antibiotics, and 1 patient had wound infection requiring vacuum dressing. No mesh was removed during the 12 month follow up period. Conclusions reported that perineal and parastomal reconstruction with biological mesh is a feasible approach for parastomal and perineal hernia prevention after laparoscopic and open elape.
 
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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
9089471100
MDR Report Key8301265
MDR Text Key134877731
Report Number1000306051-2019-00022
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
Report Date 02/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/04/2019
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 Received01/08/2019
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: 02/04/2019 Patient Sequence Number: 1
Treatment
NO INFORMATION
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