• 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 VENTRAL PATCH UNKNOWN PRODUCT 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 VENTRAL PATCH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Abdominal Pain (1685); Vomiting (2144); Abdominal Distention (2601); Not Applicable (3189)
Event Type  Injury  
Manufacturer Narrative

(b)(4). 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.

 
Event Description

It was reported that the patient underwent an umbilical hernia procedure on an unknown date and mesh was implanted. The patient reported that she experienced abdominal pain, trouble eating, vomiting and stomach swelling on one side following the procedure. An ultrasound was performed which showed the mesh. The patient later had the mesh removed on an unknown date. The patient reports that she now has fibromyalgia which requires medication. No additional information was provided.

 
Manufacturer Narrative

Pc-000075227 date sent to the fda: 06/15/2018 additional: it was reported that the patient underwent hernia procedure on (b)(6) 2011 for recurrent umbilical hernia and mesh was implanted. During the procedure the patient underwent mesh excision and adhesiolysis. Mesh patch was divided with the incision and adhesiolysis was performed after reducing the hernia. It was reported that the hernia contained omentum of the transverse colon. It was reported that there was no injury to the bowel during adhesiolysis. The mesh was completely removed from the fascia. There was a 5 cm defect, the majority of which was circumferential underlying the umbilicus, but it was skewed to the left of midline. The fascial edges were identified around the hernia defect as well as along the midline incision. It was reported that the fascia appeared to be healthy and viable. The umbilical hernia defect was closed using interrupted sutures with minimal tension. It was reported that umbilicoplasty was performed with the repair. The sutures were in a vertical array paramedian to the midline incision. The fascial edge of the hernia defect was approximately 1 cm from the midline. The midline incision fascia was closed with interrupted figure-of-eight stitches. It was reported that the umbilical hernia repair was incorporated by imbricating it with the midline figure-of-eight stitches. The deep dermis was closed with interrupted suture and skin was closed with running suture. Sterile dressing was applied.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePROCEED VENTRAL PATCH UNKNOWN PRODUCT
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville 08876 0151
Manufacturer (Section G)
ETHICON INC.
p.o. box 151, route 22 west
somerville 08876 0151
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville 08876-0151
9082182792
MDR Report Key7148978
MDR Text Key95858721
Report Number2210968-2017-71986
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
PMA/PMN NumberK061533
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/30/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/27/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
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 Received06/04/2018
Was Device Evaluated By Manufacturer? No Answer Provided
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: 12/27/2017 Patient Sequence Number: 1
-
-