MAUDE Adverse Event Report: SMITH AND NEPHEW INC., ENDOSCOPY DIVISION SMITH AND NEPHEW REGENTEN PATCH; MESH, SURGICAL, COLLAGEN, ORTHOPAEDICS, REINFORCEMENT OF TENDON

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

Patient Problems Autoimmune Disorder (1732); Fatigue (1849); Pain (1994); Arthralgia (2355)

Event Date 11/13/2019

Event Type  Injury  

Event Description

Triggered autoimmune responds; smith & nephew regenten bioinductive implant was used in a rotator cuff repair.Just several hours later i was experiencing all over joint pain through my entire body which has only continued and escalated since the surgery.I informed my doc immediately but he ignored my complaint.I now have autoimmune symptoms, skin issues, chronic fatigue, joint and muscle pain.I was in excellent health and shape until that implant.It ruined my life.My allergy doc has been trying to get components of the implant from smith and nephew, but with no luck.I am desperate for someone to hear me.All of my doctors agreed that this response was likely from the bovine patch.It has ruined my quality of life.Fda safety report id# (b)(4).

• Brand Name: SMITH AND NEPHEW REGENTEN PATCH
• Type of Device: MESH, SURGICAL, COLLAGEN, ORTHOPAEDICS, REINFORCEMENT OF TENDON
• Manufacturer (Section D): SMITH AND NEPHEW INC., ENDOSCOPY DIVISION
• MDR Report Key: 13862331
• MDR Text Key: 287818883
• Report Number: MW5108423
• Device Sequence Number: 1
• Product Code: OWY
• 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: 03/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: AMBIEN 2.5 BEFORE BED; ELDERBERRY
• Patient Outcome(s): Other; Disability
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Weight: 50 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White