MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION; MESH, SURGICAL

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

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

The reported product is an unknown baxter peri-strips psd-v with gel.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 from an anonymous survey result that the percentage of patients that had leaks or bleeds following surgery using peri-strips with gel for the reinforcement of staple lines during gastric, inclusive of small bowel surgical procedures was 1-3%.The physician reported ¿nothing is perfect but leak rate is better¿ (no further details).At the time of this report, no further detail was provided regarding if hospitalization was required, treatment for the event or the patient¿s outcome.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: 10465967
• MDR Text Key: 204729954
• Report Number: 1416980-2020-05264
• 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: 10/05/2020

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/03/2020
• Initial Date FDA Received: 08/28/2020
• Supplement Dates Manufacturer Received: 10/01/2020
• Supplement Dates FDA Received: 10/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other