• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ETHICON INC. PROCEED*SURG MESH/MULTI LYR MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number PCDG1
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Hernia (2240); Obstruction/Occlusion (2422)
Event Type  Injury  
Manufacturer Narrative

(b)(4). 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. Mwr (b)(4). Submitted for adverse event which occurred on (b)(6) 2013. Mwr (b)(4). Submitted for adverse event which occurred on (b)(6) 2015. Mwr (b)(4). Submitted for adverse event which occurred on (b)(6) 2016.

 
Event Description

It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2012 and mesh was implanted. It was reported that the patient underwent hernia repair surgery on (b)(6) 2013 and mesh was implanted. It was reported that the patient underwent partial removal surgery and recurrent hernia repair surgery in (b)(6) 2015 during which the surgeon noted the small bowel was so densely adherent to the mesh, he had no choice but to remove a portion of the mesh as well as a portion of the small bowel to which it was attached. It was reported that the patient underwent removal surgery and recurrent hernia repair surgery in (b)(6) 2016. It was reported that the patient experienced dense adhesions, small bowel obstructions and chronic intractable abdominal pain. The other procedure is captured in a separate file. No additional information was provided.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key11668410
MDR Text Key253303906
Report Number2210968-2021-03373
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK060713
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/12/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/14/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/30/2013
Device MODEL NumberPCDG1
Device Catalogue NumberPCDG1
Device LOT NumberDLG306
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 Received05/02/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/08/2011
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: 04/14/2021 Patient Sequence Number: 1
-
-