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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Adhesion(s) (1695); Nausea (1970); Pain (1994); Obstruction/Occlusion (2422); Fibrosis (3167)
Event Type  Injury  
Manufacturer Narrative
To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.
 
Event Description
It was reported by an attorney that the patient underwent hernia repair surgery on an (b)(6) 2009 and mesh was implanted.It was reported that the patient underwent removal surgery on (b)(6) 2019 during which the surgeon noted the mesh was very fibrotic.Small bowel was densely adherent to the mesh.These adhesions between the mesh and the small bowel caused pain and bowel obstruction.The surgeon took approximately two hours to remove the adhesions from the small bowel.This procedure caused 3 small bowel serosal tears requiring additional surgical repair.It was reported that the patient experienced severe, chronic pain, nausea and removal of appendix.No additional information was provided.
 
Manufacturer Narrative
Date sent to the fda: 9/30/2021.
 
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Brand Name
PROCEED MESH
Type of Device
MESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
1000 route 202
raritan NJ 08869
MDR Report Key11673824
MDR Text Key246765153
Report Number2210968-2021-03416
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K060713
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 04/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received09/28/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age43 YR
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