Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIFECELL UNKNOWN STRATTICE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

LIFECELL UNKNOWN STRATTICE Back to Search Results
Catalog Number UNK STRATTICE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hernia (2240); Post Operative Wound Infection (2446); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative
The device was not returned for evaluation and the lot number remains unknown; therefore, internal investigation into the event could not be performed.Based on the reported information, a relationship between the event and strattice cannot be determined.If additional information is reported, a follow up adverse event report will be submitted.No further actions are required as a nonconformance could not be confirmed.
 
Event Description
Literature title reviewed by medical safety department.Chegireddy v 2021 parastomal hernia repair using a silo biologic mesh the attached publication from the usa on a retrospective analysis of 22 patients who underwent parastomal hernia repair with strattice.While the authors did not name the adm used, we were able to confirm with them that it was strattice in all cases.The authors report the following complications wound healing, infection, reherniation, and reoperation.Conclusions: this silo technique is associated with favorable complication and low recurrence rates compared with the available techniques in surgical literature.In our practice, it has established itself as a new and safe technique for complex or recurrent pshs and should be considered in a surgeon's armamentarium.This technique has become our standard for treatment of recurrent pshs.
 
Manufacturer Narrative
The previous submission was made with a blank g3 field.The g3 field for the previous submission is [enter aware date].The previous submission was made within 30 days of the date received by manufacturer.A capa is opened to address the issue.
 
Event Description
The previous submission was made with a blank g3 field.The g3 field for the previous submission is [enter aware date].The previous submission was made within 30 days of the date received by manufacturer.A capa is opened to address the issue.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
UNKNOWN STRATTICE
Type of Device
UNKNOWN STRATTICE
Manufacturer (Section D)
LIFECELL
one millennium way
branchburg NJ 08876
MDR Report Key12051593
MDR Text Key258428028
Report Number1000306051-2021-00037
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 literature
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/23/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNK STRATTICE
Was Device Available for Evaluation? No
Date Manufacturer Received04/26/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age66 YR
-
-