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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PROCEED*SURG MESH/MULTI LYR MESH, SURGICAL, POLYMERIC

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ETHICON INC. PROCEED*SURG MESH/MULTI LYR MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number PCDH1
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Adhesion(s) (1695); Diarrhea (1811); Inflammation (1932); Nausea (1970); Pain (1994); Chills (2191); Hernia (2240); Weight Changes (2607); Decreased Appetite (4569)
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 (b)(6) 2017 and mesh was implanted. It was reported that the patient underwent revision surgery on (b)(6) 2019 during which the surgeon noted he took down the intestinal adhesions struck to the mesh and repaired the recurrent hernia. It was reported that the patient experienced severe pain, nausea, diarrhea, chills, inflammation, loss of appetite and extreme weight loss. No additional information was provided.
 
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Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
1000 route 202
raritan NJ 08869
MDR Report Key12602957
MDR Text Key279812300
Report Number2210968-2021-09456
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 10/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/10/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/31/2019
Device Model NumberPCDH1
Device Catalogue NumberPCDH1
Device Lot NumberLCG126
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/01/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/26/2017
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: 10/10/2021 Patient Sequence Number: 1
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