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

Model Number PCDG1

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

Patient Problems Adhesion(s) (1695); Diarrhea (1811); Inflammation (1932); Nausea (1970); Pain (1994); Chills (2191); Obstruction/Occlusion (2422); Weight Changes (2607); Decreased Appetite (4569)

Event Type  Injury  

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-11082021-0001016027 submitted for adverse event which occurred on (b)(6) 2008. Mwr-11082021-0001016029 submitted for adverse event which occurred on (b)(6) 2010.

Event Description

It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2008 and mesh was implanted. It was reported that the patient underwent removal surgery and hernia repair surgery on (b)(6) 2008 and mesh was implanted during which the surgeon noted the left edge of the fascia was separating from the mesh, as well as one segment of the bowel that was stuck to the mesh and was very friable. It was reported that the patient underwent removal surgery on (b)(6) 2010 during which the surgeon noted the small bowel to be densely adherent to the mesh, resulting in a resection of the portion of the bowel and mesh attached to it. It was reported that the patient experienced severe pain, nausea, diarrhea, chills, inflammation, loss of appetite and extreme weight loss. Other procedure is captured under separate file. No additional information was provided.

• Type of Device: MESH, 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 Key: 12310847
• MDR Text Key: 266173769
• Report Number: 2210968-2021-07256
• 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
• Report Date: 08/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: PCDG1
• Device Catalogue Number: PCDG1
• 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: 10/20/2021
• 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: 08/11/2021 Patient Sequence Number: 1