MAUDE Adverse Event Report: ATRIUM MEDICAL C-QUR V-PATCH; MESH, SURGICAL, POLYMERIC

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

Patient Problems Anemia (1706); Anemia (1706); Dehydration (1807); Dehydration (1807); Dysphagia/ Odynophagia (1815); Edema (1820); Edema (1820); Hearing Loss (1882); High Blood Pressure/ Hypertension (1908); High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914); Low Blood Pressure/ Hypotension (1914); Hypoxia (1918); Hypoxia (1918); Unspecified Infection (1930); Unspecified Infection (1930); Inflammation (1932); Inflammation (1932); Nausea (1970); Nausea (1970); Nerve Damage (1979); Nerve Damage (1979); Scarring (2061); Scarring (2061); Sepsis (2067); Sepsis (2067); Septic Shock (2068); Septic Shock (2068); Seroma (2069); Seroma (2069); Vomiting (2144); Vomiting (2144); Hernia (2240); Hernia (2240); Impaired Healing (2378); Impaired Healing (2378); Respiratory Failure (2484); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

We are unable to fully investigate this event as no product code, lot number, or sample was provided.This report is based upon allegations made in a lawsuit in which atrium medical is named as a defendant.This report shall not be considered as an admission by atrium medical that the product described in the lawsuit claim and described herein is or was defective, or that it had any causal relationship to any injuries allegedly suffered by the plaintiff.

Event Description

This event is deemed reportable based on the allegations in a lawsuit which, while unsubstantiated, suggest that a reportable event may have occurred during use of atrium medical¿s mesh product.Plaintiff allegedly experienced infection, sepsis, sirs, septic shock, ileus, seroma formation, edema, improper wound healing, sequelae from infection, excessive and chronic inflammation, bowel obstruction, hypertension, hypotension, nerve damage, bilateral hearing loss, diarrhea, nausea, vomiting, dehydration, respiratory failure with hypoxia, oropharyngeal dysphagia, acute kidney injury, nerve damage, normocytic anemia, scarification, additional surgery and recurrence of hernia.Since this is a legal matter, the case has been turned over to legal counsel and further information obtained through investigation or discovery may fall under the attorney/client and/or work product privilege.However, atrium will supplement this report as appropriate if additional information comes to its attention.

Event Description

Plaintiff allegedly also experienced hemodynamic instability and a hematoma.

• Brand Name: C-QUR V-PATCH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• Manufacturer (Section G): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• Manufacturer Contact: 40 continental blvd; merrimack, NH 03054
• MDR Report Key: 7652695
• MDR Text Key: 112841542
• Report Number: 3011175548-2018-00672
• Device Sequence Number: 0
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K080688
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/29/2018
• 2 Devices were Involved in the Event: 1 2

2 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/17/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 0
• Patient Outcome(s): Required Intervention