MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PERI-STRIPS DRY WITH VERITAS COLLAGEN MATRIX CIRCULAR; MESH, SURGICAL

Model Number	PSD25V
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Vomiting (2144); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported peri-strips ¿did not work¿ and the patient could not ¿keep food down.¿ the patient underwent a laparoscopic gastric bypass wherein peri-strips with staples were applied at the g-j anastomosis.Two to four weeks postoperatively the patient developed food intolerance by vomiting up any type of food the patient ate requiring an esophagogastroduodenoscopy (egd) which showed a stricture at the gj anastomosis.The area was balloon dilated.The surgeon had to go in and repair the perforation.No further information was available at the time of this report.
Additional Manufacturer Narrative
Additional information: h6 and h11.H11: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PERI-STRIPS DRY WITH VERITAS COLLAGEN MATRIX CIRCULAR
• Common Device Name: MESH, SURGICAL
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - SAINT PAUL; 2575 university ave w; saint paul MN 55114
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 21965234
• Report Number: 1416980-2025-02696
• Device Sequence Number: 8111766
• Product Code: FTM
• UDI-Device Identifier: 00085412531311
• UDI-Public: (01)00085412531311(10)SP24J092153339(17)280216
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2025

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
• Operator of Device: Health Professional
• Device Model Number: PSD25V
• Device Catalogue Number: PSD25V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2025
• Supplement Date Received by Manufacturer: 05/14/2025
• Initial Report FDA Received Date: 05/05/2025
• Supplement Report FDA Received Date: 06/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EEA ORVIL 25MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown