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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 PCDD1
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/01/2021
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (b)(4). Additional information was requested and the following was obtained: is the product/package available for analysis? entire product line affected any photos available for visual analysis? yes, attached in document is there an indication of how the product was distributed? unknown, user not a distributor is there any indication of the source? labeling defect. Source of label creation. Was another type of scanner used, to attempt reading the labels? unicode embedded in barcode identified; udi-pi contained in barcode and missing human-readable indicator what type of bar code is being scanned? all barcodes on the package and peelpack do you think there were any changes /updates to packaging/design etc? no, this is a labeling at origin issue.
 
Event Description
It was reported that on an unknown date in 2021 the mesh was used. It was reported that the barcode did not hit the ¿good id¿ when scanned. It was also reported that when the barcode was scanned it 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
MDR Report Key12443448
MDR Text Key280588743
Report Number2210968-2021-08186
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 company representative,user f
Type of Report Initial,Followup
Report Date 08/10/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2021
Device Model NumberPCDD1
Device Catalogue NumberPCDD1
Device Lot NumberPPG189
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/24/2021
Is This a Reprocessed and Reused Single-Use Device?

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