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

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

Patient Problems Abdominal Pain (1685); Fever (1858); Inflammation (1932)

Event Date 12/31/2020

Event Type  Injury  

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 a patient underwent a laparoscopic simple total hysterectomy, right adnexectomy, and left salpingectomy in which seprafilm was used.Seven days after surgery, the patient was discharged from the hospital.Two days later, the patient was hospitalized for fever and abdominal pain, subsequently the patient was diagnosed with postoperative inflammation of pelvic dead space.It was reported "the onset site was different from the application site", rated as mild severity.The patient was treated with unspecified antibiotics for the event.Two days later an ileus was noted.The following day the patient was discharged from the hospital and was recovered from the events of fever and abdominal pain.At the time of this report, the patient outcome of postoperative inflammation of pelvic dead space and ileus was unknown.No additional information is available.

• Brand Name: SEPRAFILM
• Type of Device: BARRIER, ABSORABLE, ADHESION
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): GENZYME CORPORATION; 1 and 74-80 new york avenue; framingham MA 01701
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 11240217
• MDR Text Key: 229093371
• Report Number: 1416980-2021-00221
• Device Sequence Number: 1
• Product Code: MCN
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/27/2021

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/08/2021
• Initial Date FDA Received: 01/27/2021
• 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
• Treatment: REDUCER SLEEVE
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR