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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 PCDG1
Device Problem Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/02/2020
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (b)(4). A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.     evaluation: photos were returned for analysis. Upon visual inspection of the pictures, the box with lot number # could be observed. However, the mesh was not visible. The product was also returned for evaluation. Visual inspection evaluation was conducted on the returned device. Visual analysis of the returned sample determined that one opened sample of product was received for evaluation, the mesh was received torn in the foil packet and several damage could be observed as a result of the process of degradation beginning. The foil was inspected and multiples holes in cavity and excessive wrinkles were noted. This condition contributed to degradation process. As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch. Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance. If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
 
Event Description
It was reported that a patient underwent a ventral hernia repair procedure on (b)(6) 2020 and the mesh was implanted. During surgery, when the surgeon tried to put the mesh through the 12 mm port it was found that the mesh was torn and defective. The surgery was delayed for ten minutes. A competitor device was used to successfully complete the procedure. Upon evaluation of the returned sample it was found that the mesh was received torn in the foil packet and several damages as a result of the degradation process which had begun. There were no adverse patient consequences reported.
 
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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 30531
Manufacturer Contact
elba bello
1000 route 202
raritan, NJ 08869
MDR Report Key11817243
MDR Text Key250374340
Report Number2210968-2021-04531
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K060713
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial
Report Date 04/13/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2020
Device Model NumberPCDG1
Device Catalogue NumberPCDG1
Device Lot NumberMKG236
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/12/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/12/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/13/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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