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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 PCDN1
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
(b)(4). A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified. 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. Can you confirm that the barcode label mentioned refers to the product traceability label found in the photo you provided? are you using your own proprietary software to scan the barcode, obtain udi product data from the usfda¿s gudid website, and import the data into the xcelerate udi application?.
 
Event Description
It was reported that the mesh was used on an unknown date. It was reported that there was an issue with the packaging of the device. It was reported that the barcode did not hit the ¿good id¿ when scanned. It was also reported that the when scanned the barcode gave the phone number, but did not give the email address or product information. There were no adverse patient consequences reported. Additional information was requested.
 
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Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
1000 route 202
raritan NJ 08869
Manufacturer (Section G)
ETHICON INC.-CORNELIA
655 ethicon circle
cornelia GA
Manufacturer Contact
elba bello
1000 route 202
raritan, NJ 08869
MDR Report Key12914600
MDR Text Key286136170
Report Number2210968-2021-12260
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K060713
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/03/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/30/2021
Device Model NumberPCDN1
Device Catalogue NumberPCDN1
Device Lot NumberPKG159
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received12/21/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/21/2019
Is the Device Single Use? Yes
Type of Device Usage Initial

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