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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 Abdominal Pain (1685); Adhesion(s) (1695); Scarring (2061)
Event Type  Injury  
Manufacturer Narrative
This legal complaint is being reported in an abundance of caution due to the alleged serious injuries. Based on the reported information, it is unclear regarding the timeline of the adverse events for scarring, adhesions and other serious injuries including chronic abdominal pain and therefore cannot be confirmed if the strattice device was involved in the post-operative complications or if strattice caused or contributed to the events reported. The patient's alleged recurrent hernias occurred with another manufacturer's mesh product prior to the implantation of strattice. Due to the legal process, no follow up attempts can be performed for patient and procedure specific information, including the relevant strattice lot number, implant dates or patient's medical records. Without the associated lot number, an internal investigation cannot be performed. At this time, a relationship to strattice cannot be determined. If additional information is received through the legal process, a follow up report will be submitted. This report concludes our investigation.
 
Event Description
A legal complaint was received against strattice. The plaintiff alleges that they underwent a ventral hernia repair on (b)(6) 2010 with another manufacturer's hernia mesh product. Subsequently, they underwent multiple surgeries due to the mesh implant failure causing recurrent hernias, which resulted in them being implanted with a strattice matrix and another manufacturer's mesh product, as well as other adverse reactions including significant scarring and adhesions and other serious injuries including chronic abdominal pain. As a result of having the "hernia mesh products" implanted, the plaintiff alleges significant mental and physical pain and suffering and mental anguish, has sustained permanent injury, has undergone medical treatment and will likely undergo further medical treatment and procedures.
 
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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 Key7601102
MDR Text Key111052285
Report Number1000306051-2018-00080
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 other
Reporter Occupation
Type of Report Initial
Report Date 06/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/14/2018
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? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/17/2018
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: 06/14/2018 Patient Sequence Number: 1
Treatment
NO INFORMATION
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