MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION MESH, SURGICAL

Catalog Number PSD6006UV

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

Patient Problem Injury (2348)

Event Date 10/02/2019

Event Type  Injury  

Manufacturer Narrative

The reported product is an unknown baxter peri-strip. 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 eight peri-strips were used with eight staple fires. It was reported that the hospital was out of naked non-baxter staple loads and ¿removed the buttress from the pre-loads, then adhered the peri-strips to them¿. On an unreported date, 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 reported the patient required a ¿redo¿ (additional surgical intervention due to the leak) and went to a different facility. 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: 10495412
• MDR Text Key: 205711466
• Report Number: 1416980-2020-05490
• 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,Followup
• Report Date: 10/07/2020

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: PSD6006UV
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/02/2020
• 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