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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PROCEED MESH MESH, SURGICAL, POLYMERIC

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ETHICON INC. PROCEED MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problem Material Split, Cut or Torn (4008)
Patient Problem Adhesion(s) (1695)
Event Date 01/01/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4). Device not returned.    attempts are being made to obtain the following information.   to date no response has been provided. If further details are received at a later date a supplemental medwatch will be sent. The patient demographic info: weight, bmi at the time of index procedure date of initial surgical procedure. What were current symptoms following the index surgical procedure? onset date? what are the patient comorbidities/concomitant medications? what was surgical approach (open, laparoscopic or other)? any concurrent surgeries or procedures? were pre-existing adhesions noted during the procedure? location and severity of adhesions? please provide details of surgical intervention for adhesion. What is the relationship of adhesion to device implanted? product code and lot #. What is physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status?  .
 
Event Description
It was reported that a patient underwent an umbilical hernia procedure on an unknown date in 2014 and the mesh was implanted. The patient returned in 2021 for a another surgery and found that the device had a hole in the middle of the mesh. The patient had adhesions taken down and a competitor's mesh was placed over the hole in the existing hernia mesh. The procedure and patient outcome is unknown.
 
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Brand NamePROCEED MESH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
1000 route 202
raritan NJ 08876
Manufacturer (Section G)
ETHICON INC.-CORNELIA
655 ethicon circle
cornelia GA 30531
Manufacturer Contact
elba bello
1000 route 202
raritan, NJ 08876
9082182213
MDR Report Key11579928
MDR Text Key243916613
Report Number2210968-2021-02817
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeSF
PMA/PMN Number
K060713
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/27/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
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 Received05/20/2021
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?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/27/2021 Patient Sequence Number: 1
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