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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIFECELL UNKNOWN CONEXA MESH, SURGICAL

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LIFECELL UNKNOWN CONEXA MESH, SURGICAL Back to Search Results
Catalog Number UNK CONEXA
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Post Operative Wound Infection (2446)
Event Type  Injury  
Manufacturer Narrative

Initial reporter: corresponding author and institution. This mdr is being reported as an individual event type as serious injury due to the reported infection with medical and surgical intervention. Multiple attempts were made to contact the corresponding author for additional information, including relevant lot numbers. To date, no additional information has been obtained. The lot number associated with this event remains unknown; therefore an internal investigation could not be performed. Based on the reported information, a relationship between the event and the conexa cannot be determined. No further actions are required; a nonconformance could not be confirmed. If additional information is received, a supplemental report will be submitted.

 
Event Description

During a literature review, an article titled "surgical repair of large-to-massive rotator cuff tears seems to be a better option than patch augmentation or débridement and biceps tenotomy: a prospective comparative study" reported a prospective study from october 2012 to july 2016 of 32 consecutive patients to compare the outcomes after 3 different treatments for large and massive rotator cuff tears. Eleven patients (5 male, 6 female, mean age 56 years) in the patch group received conexa. Patients were evaluated before and after the operation at 3, 6, 12 and 24 months. This mdr is associated with the conexa complications only. In the patch group, 1 deep infection required the removal of the patch and antibiotic treatment. It was confirmed that this complication was not previously reported as a complaint to lifecell at the time of the event.

 
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Brand NameUNKNOWN CONEXA
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 Key7991534
MDR Text Key124592942
Report Number1000306051-2018-00130
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeFR
PMA/PMN NumberK080353
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
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 HEALTH PROFESSIONAL
Device Catalogue NumberUNK CONEXA
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 Received09/25/2018
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: 10/22/2018 Patient Sequence Number: 1
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