MAUDE Adverse Event Report: LIFECELL CORPORATION STRATTICE RECONSTRUCTIVE HENIA MESH; MESH, SURGICAL

Model Number 1620002P

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

Patient Problems Abdominal Pain (1685); Fatigue (1849); Pain (1994); Seroma (2069)

Event Date 03/08/2022

Event Type  Injury  

Event Description

Hernia repair.My implant is strattice lifecell recon perforate, 20cmx16cm.My abdominal pain is out of control and has been since date of surgery (b)(6) 2022.I have developed seroma, awful bowels, fatigue all with level 8-10 pains every day.Bilateral leg pains that have intensified since surgery.I have been to the er post surgery for pain.High reactive lymphocytes.Seen the surgeon a few times for help.None offered.Seen pain management doctor and my pcp.Will be talking with doctor for discussing mesh removal.This is inhumane on how i feel every day and being dismissed by the surgeon who put the mesh in.Fda safety report id # (b)(4).

• Brand Name: STRATTICE RECONSTRUCTIVE HENIA MESH
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): LIFECELL CORPORATION
• MDR Report Key: 14469876
• MDR Text Key: 292499450
• Report Number: MW5109810
• Device Sequence Number: 1
• Product Code: FTM
• 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: 05/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 1620002P
• Device Catalogue Number: 1620002P
• Device Lot Number: SP200223-043
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/20/2022
• Patient Sequence Number: 1
• Treatment: BALANCE OF NATURE; ESTRACE; GABAPENTIN ; MELATONIN ; NEXIUM 24; PROBIOTIC ; PROBIOTIC ; TIZANIDINE; TYLENOL PM
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Weight: 66 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White