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 Blood Loss (2597)

Event Date 04/02/2020

Event Type  Injury  

Manufacturer Narrative

The reported product is an unknown baxter peri-strip. (b)(6). Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a patient underwent an unspecified gastric tissue surgery in which peri-strips were used. After application of the peri-strips, the physician tried to suture through the peri-strips, however, the stitches pulled the peri-strips off the tissue, which resulted in bleeding. The estimated volume of blood loss was 50 ml. Treatment for the event was not reported. At the time of this report, the patient outcome was reported as the ¿length of surgery was prolonged due to the bleeding¿. 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: 9999992
• MDR Text Key: 188968499
• Report Number: 1416980-2020-02374
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2020
• 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?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/27/2020
• 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: Unkown

Patient Treatment Data

Date Received: 04/27/2020 Patient Sequence Number: 1