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

Model Number PCDM1

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

Patient Problems Granuloma (1876); Nausea (1970); Loss of consciousness (2418)

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) 2012 and mesh was implanted. It was reported that the patient underwent removal surgery on (b)(6) 2018 during which the surgeon noted the mesh that was around the umbilicus but in a horizontal orientation. There did appear to be an area of granuloma that was removed with electrocautery. Electrocautery was then sued to carefully remove the mesh from the undersurface of the abdominal wall. It was reported that the patient experienced severe pain, at times loss of consciousness, nausea, diarrhea, chills, inflammation and loss of appetite. No additional information is provided.

• Type of Device: MESH, 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 ; 9082183429
• MDR Report Key: 10549945
• MDR Text Key: 207512855
• Report Number: 2210968-2020-06987
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (Y/N): N
• Reporter Country Code: US
• PMA/PMN Number: K060713
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: OTHER

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 09/16/2020

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 09/17/2020
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: HEALTH PROFESSIONAL
• Device EXPIRATION Date: 12/31/2013
• Device MODEL Number: PCDM1
• Device Catalogue Number: PCDM1
• Device LOT Number: EAG003
• 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 Received: 03/24/2021
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 01/18/2012
• 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: 09/17/2020 Patient Sequence Number: 1