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.

Manufacturer Narrative

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.

• Brand Name: NI
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• 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
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PSD6006UV
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/12/2020
• Initial Date FDA Received: 09/04/2020
• Supplement Dates Manufacturer Received: 10/02/2020
• Supplement Dates FDA Received: 10/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention