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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 Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/22/2021
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (b)(4). Photos of the product upon which this medwatch is based have been received, however, the product evaluation is not yet complete. Any further information derived from the evaluation will be submitted in a supplemental 3500a form to date the device has not been returned. If the device or further details are received at a later date a supplemental medwatch will be sent.  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 hernia repair on (b)(6) 2021 and the mesh was implanted. It was reported that there was a tearing up of the device at the site where the device was fixated. It was also reported that the surgery was delayed for fifteen minutes. It was reported that the procedure was successfully completed with the same mesh and absorbable straps to repair the mesh. It was also reported that the surgeon is expecting a recurrence of hernia as a result of the mesh tearing. 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 GA 30531
Manufacturer Contact
elba bello
1000 route 202
raritan, NJ 08869
MDR Report Key11701007
MDR Text Key246760922
Report Number2210968-2021-03585
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 company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/22/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2021
Device Model NumberPCDH1
Device Catalogue NumberPCDH1
Device Lot NumberPJG130
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/11/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/21/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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