MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PERI-STRIPS MESH, SURGICAL

Catalog Number PSDA60ECH

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/12/2021

Event Type  Injury  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported two (2) peri-strips were placed on a patient "with the adhesive covering still on". The event occurred in the operating room and was further described as ¿the technician placed glue on top of the adhesive liner instead of removing the liner. A different technician switched in midway through the procedure. The surgeon then placed the peri-strips onto the patient¿s abdomen in that condition. The technician then noticed that the per-strips looked different and realized the error; however, the procedure was completed with the per-strips left in with liners attached as the surgeon stated they did not have a lot of room to go back and remove the liners. At the time of the follow up the liners were in the patient¿. There was no patient injury or medical intervention associated with this event. No additional information is available.

• Brand Name: PERI-STRIPS
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): SYNOVIS SURGICAL INNOVATIONS; 2575 university ave w; saint paul MN 55114
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 12416314
• MDR Text Key: 269612443
• Report Number: 1416980-2021-05403
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K192615
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: PSDA60ECH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2021
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 09/02/2021 Patient Sequence Number: 1