MAUDE Adverse Event Report: ETHICON INC. PROCEED VENTRAL PATCH UNKNOWN PRODUCT; MESH, SURGICAL, POLYMERIC

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Perforation (2001); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/04/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.(b)(4).Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.If in your possession, may we have a copy of your operative report? does ethicon have your permission to contact your surgeon, in the event ethicon would like to contact your surgeon for more clinical information to be used for a product quality complaint investigation? if so, please provide your surgeon¿s name, contact information and sign release of medical information form attached.

Event Description

It was reported that a patient underwent an inguinal and umbilical hernia repair on an unknown date in 2011 and the mesh was implanted.It was reported that on (b)(6) 2021, the patient had emergency surgery for an intestinal wall perforation that led to bleeding.It was also reported that the device was replaced and the patient is now doing fine.Additional information was requested.

Manufacturer Narrative

Product complaint#: (b)(4).Mfr#: 2210968-2022-00751 is being retracted since it was found to be a duplicate of mfr#: 2210968-2022-01106.2210968-2022-01106 will be kept for investigation purposes.

• Brand Name: PROCEED VENTRAL PATCH UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-GMBH; robert-koch strasse 1; p.o. box 1409 D2284 1; GM D22841
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13401406
• MDR Text Key: 285452440
• Report Number: 2210968-2022-00751
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061533
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2022
• 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
• Date Manufacturer Received: 03/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male