• 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 Diarrhea (1811); Unspecified Infection (1930); Inflammation (1932); Nausea (1970); Pain (1994); Chills (2191); Decreased Appetite (4569)
Event Type  Injury  
Event Description
It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2009 and mesh was implanted. It was reported that the patient underwent partial removal surgery on (b)(6) 2014 during which the surgeon noted a portion of the mesh at the base of the wound abscess. It was reported that the patient underwent partial removal surgery on (b)(6) 2014 during which the surgeon noted there was inflammatory tissue at the base of the wound involving the mesh. He then excised all visible mesh but left a significant amount in due to incorporation. It was reported the patient underwent partial removal surgery on (b)(6) 2014 during which the surgeon noted he was able to remove all the mesh on the left side of the peritoneal cavity, despite adhesions, and he then discovered a portion of the mesh was intraluminal to her small bowel, with resulting small bowel to mesh fistula, necessitating a small bowel resection. It was reported that the patient experienced severe pain, nausea, diarrhea, chills, inflammation, loss of appetite and has a large dense in her abdomen due to multiple surgeries and infections. ¿ no additional information was provided.
 
Manufacturer Narrative
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) 2014. Mwr# (b)(4), submitted for adverse event which occurred on (b)(6) 2014. Mwr# (b)(4), submitted for adverse event which occurred on (b)(6) 2014.
 
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 Key14139015
MDR Text Key289613967
Report Number2210968-2022-02732
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 Other
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/18/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/31/2010
Device Model NumberPCDG1
Device Catalogue NumberPCDG1
Device Lot NumberAPG714
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received05/13/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/08/2009
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: 04/18/2022 Patient Sequence Number: 1
-
-