MAUDE Adverse Event Report: US SURGICAL PUERTO RICO UNKNOWN PROTACK; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number UNKNOWN PROTACK

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

Patient Problems Unspecified Infection (1930); Unintended Radiation Exposure (4565)

Event Date 12/21/2021

Event Type  Injury  

Event Description

According to literature source of study performed between june 2012 and august 2018, postoperative to laparoscopic ventral mesh rectopexy for rectal prolapse, patient experienced discitis near the site of fixation of the mesh to the sacral promontory.This was diagnosed with magnetic resonance imaging and treated with antibiotics.

Manufacturer Narrative

Title: mesh safety in pelvic surgery: our experience and outcome of biological mesh used in laparoscopic ventral mesh rectopexy source: world journal of clinical cases 2022 january 21; 10(3): 891-898.If information is provided in the future, a supplemental report will be issued.

• Brand Name: UNKNOWN PROTACK
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer (Section G): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer Contact: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 13652943
• MDR Text Key: 286446265
• Report Number: 2647580-2022-00679
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN PROTACK
• Device Catalogue Number: UNKNOWN PROTACK
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/15/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention