MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION MESH, SURGICAL

Catalog Number ASKU

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

Patient Problem Injury (2348)

Event Date 06/03/2020

Event Type  Injury  

Manufacturer Narrative

The reported product is an unknown baxter peri-strip. The device was not returned, and the lot number is unknown; therefore, a device analysis could not be completed. Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported a patient underwent a gastric sleeve procedure in which five peri-strips were used on eight staple fires. On an unreported date following surgery, the patient experienced a post-operative leak. The location of the leak was in the "upper 2 cm of the stomach". The cause of the leak was unknown. It was reported the patient required an extended hospitalization due to the leak. It was unknown if any medical intervention was associated with this event. At the time of this report, the patient outcome was unknown. No additional information is available.

• Brand Name: NI
• 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 60073 ; 2242702068
• MDR Report Key: 10494464
• MDR Text Key: 205683648
• Report Number: 1416980-2020-05464
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial
• Report Date: 09/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/12/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 09/04/2020 Patient Sequence Number: 1

Treatment

COVIDIEN PRE-BUTTRESS