• 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 PCDH1
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Adhesion(s) (1695); Diarrhea (1811); Inflammation (1932); Nausea (1970); Necrosis (1971); Pain (1994); Perforation (2001); Chills (2191); Obstruction/Occlusion (2422); Weight Changes (2607); Decreased Appetite (4569); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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.

 
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 omentectomy and partial removal of the previous mesh during which the surgeon noted ¿the entire right side of the previously placed mesh had completely pulled apart from the fascia along almost the entirety of the right fascial border. Multiple omental adhesions had to be taken down form the mesh to obtain surgical exposure. After these adhesions were taken down, a portion of the omentum extremely adherent to the mesh had been dissected away from it. ¿ it was reported that the patient underwent partial removal on (b)(6) 2010 during which the surgeon noted ¿the mesh was densely adherent to the small bowel. Portions of old mesh that were not adherent to small bowel were excised with scissors. Approximately 50% of operative time was spent lysing extensive adhesions. Upon closer inspection, a tiny enterotomy without any spillage of succus was found. ¿ it was reported that the patient experienced limited to partial and full obstructions of the intestines, small intestine perforations, small intestine injuries, infection, abdominal wall reconstruction, adhesions, chronic inflammation, partial omentectomy, enterotomy, re-anastomosis, necrosis, loss of abdominal wall integrity, severe pain, nausea, diarrhea, chills, inflammation, loss of appetite, and extreme weight loss. The patient had a previous mesh implantation on (b)(6) 2008 which 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.
p.o. box 151, route 22 west
somerville NJ 08876
Manufacturer (Section G)
ETHICON INC.-CORNELIA
655 ethicon circle
cornelia GA 30531
Manufacturer Contact
elba bello
p.o. box 151, route 22 west
somerville, NJ 08876
9082182213
MDR Report Key11580187
MDR Text Key246218576
Report Number2210968-2021-02824
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
Report Date 03/23/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/27/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberPCDH1
Device Catalogue NumberPCDH1
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/22/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 03/27/2021 Patient Sequence Number: 1
-
-