MAUDE Adverse Event Report: COVIDIEN HERNIA MESH MESH, SURGICAL, POLYMERIC

Lot Number A8D0558Y

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Abdominal Pain (1685); Cyst(s) (1800); Fatigue (1849); Failure of Implant (1924); Pain (1994); Swelling/ Edema (4577)

Event Type  Injury  

Event Description

On (b)(6) of 2019 i had an inguinal hernia repaired with covidien mesh. In (b)(6) or (b)(6) of 2020 i started to experience abdominal pain, swelling, tenderness as well as extreme fatigue. As of (b)(6) 2020 my primary care doctor took me out of work and i have been unable to return to work since. I just recently got approved for ssdi due to complications caused by the hernia mesh. I have been to the er on at least 3 separate occasions for this abdominal pain located on the right side groin area. The er ran some tests including blood tests, ex ray, ct scans, transvaginal ultrasound and eventually an ultrasound. However, the er physicians and nurses were all covering for the surgeon who performed the surgery (dr. (b)(6)) so they were trying to shift the attention on something else. They had seen an ovarian cyst located on my left side when i went to the emergency room complaining of pain on my right side. The surgery was performed at (b)(6) hospital in (b)(6). I had 4 post op appointments with the surgeon and each time he denied the pain was coming from the mesh and when i asked him to remove the mesh, he said that the procedure was "too involved" and sent me back to work despite the pain i was in and am still in. I went back to primary care physician and that is when i was taken out of work ((b)(6) 2020). Fda safety report id# (b)(4).

• Brand Name: HERNIA MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 13425181
• MDR Text Key: 285063206
• Report Number: MW5107139
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Lot Number: A8D0558Y
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No Answer provided

Patient Treatment Data

Date Received: 02/01/2022 Patient Sequence Number: 1

Treatment

ESTRADIOL PATCH; GABAPENTIN 100MG AND 300MG ; SERTRALINE100MG