MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION SEPRAFILM; BARRIER, ABSORBABLE, ADHESION

Model Number	430102
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/12/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4 udi: as the lot # is unknown, the udi will consist of the primary di number only.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 or Problem Description
It was reported that two (2) seprafilm adhesion barriers were used during a partial pelvic peritonectomy.The patient, with a medical history including adenomyosis, bilateral ovarian chocolate cysts, and severe pelvic endometriosis adhesions, underwent a single-port robotic hysterectomy with bilateral ovarian tumor resection and pelvic endometriosis resection.During partial pelvic peritoneectomy, two seprafilm sheets were used to completely adhere to the pelvic floor.The incisions after peritoneal removal, the superficial layer of the right ureter, and the vaginal incision after uterine removal were also addressed.Considering the single-port surgery and intraoperative blood loss of less than 100 ml, no drainage tube was placed.The patient developed fever, nausea, vomiting, and abdominal distension on the second postoperative day.A ct scan revealed paralytic ileus, and approximately 150 ml of fluid was found in the pelvic floor.Blood tests showed wbc: 15000, segmented eclampsia: 80, crp: 169.Therefore, the patient received continuous antibiotic and anti-inflammatory medication for control.By the 14th day post surgery, the patient was able to eat and defecate normally but continued to have watery vaginal discharge.Therefore, a second operating room visit was conducted to remove a large amount of colloidal fluid.Significantly inflamed tissue remained, with severe adhesions between the lower colon and right ureter.Inflammation and compression of the right ureter had led to narrowing, necessitating the placement of a ureteral catheter.By the 15th day post surgery, the patient's vital signs were stable.Diet and urination were continuously monitored.All blood and body fluid cultures were sterile.Crp stabilized at 38, wbc count had decreased to 7000, and segmentation: 66.Follow-up imaging showed no signs of ileus.No additional information is available at this time.

• Brand Name: SEPRAFILM
• Common Device Name: BARRIER, ABSORBABLE, ADHESION
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): SANOFI GENZYME; 11 forbes rd.; attn: receiving department; northborough MA 01532
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242705355
• MDR Report Key: 25682160
• Report Number: 1416980-2026-02209
• Device Sequence Number: 4671089
• Product Code: MCN
• UDI-Device Identifier: 05413765589614
• UDI-Public: (01)05413765589614
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: P950034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/01/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 430102
• Device Catalogue Number: 430102
• 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: 06/01/2026
• Initial Report FDA Received Date: 07/01/2026
• 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: DA VINCI ROBOT.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 33 YR
• Patient Sex: Female