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 Code	Stenosis (2263)
Date of Event	10/08/2024
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 that peri-strips with veritas collagen matrix circular was used during a roux-en-y surgery (gastric bypass) and a patient developed tight strictures 3 to 5 weeks post-operatively.The patient received egd with dilation; however, the strictures appear to have increased inflammation and were more resistant to balloon dilation than usual.It was not reported if the patient required prolonged hospitalization.The patient outcome was also not reported.No additional information is available.
Additional Manufacturer Narrative
Additional information: d4: lot #, d4: expiration date, h6 and h11.D4: lot #: it was reported the exact lot number was unknown; however, the reported expiration date was 01/05/2028.The lot numbers that expire on 01/05/2028 are sp23i06-1933813 or sp23k27-1981134.These are both potential lot numbers.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: 21036103
• Report Number: 1416980-2024-07664
• Device Sequence Number: 15561866
• Product Code: FTM
• UDI-Device Identifier: 00085412531311
• UDI-Public: (01)00085412531311
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2025

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2024
• Supplement Date Received by Manufacturer: 01/02/2025
• Initial Report FDA Received Date: 12/30/2024
• Supplement Report FDA Received Date: 01/28/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown