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

Catalog Number PSDA60ECH

Device Problem Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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.

Event Description

It was reported that during use of peri-strips, the physician experienced four to five different occurrences in which "the jaws would not open up as easy".The type of surgery and patient outcome were unknown.There was no report of patient injury or medical intervention.No additional information is available.

• Brand Name: PERI-STRIPS
• 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: 10551272
• MDR Text Key: 207507720
• Report Number: 1416980-2020-05796
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K192615
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PSDA60ECH
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/21/2020
• Initial Date FDA Received: 09/17/2020
• 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 Sequence Number: 1