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

Catalog Number 638005

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

Patient Problems Abscess (1690); Fever (1858)

Event Date 11/01/2022

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

A patient underwent a total laparoscopic hysterectomy in which seprafilm was used.Seprafilm was applied to pelvic floor and uterine stump sutures.Five days post-operative the patient was discharged home.The following day, the patient experienced a fever (38.9°c) and was diagnosed with a pelvic floor abscess (based on echo examination result).Tazopipe drip infusion (4.5 g) was administered.The following day, the patient was hospitalized with a fever of (37.8°c).The patient was started on tazopipe (4.5g x 3/1 day) and chloramphenicol vaginal tablet (100mg x 1/1 day) for three days.The following day the patient was discharged.The following day, the patient presented with a fever of 37.8 and was subsequently hospitalized.The patient was treated with meropen point (drop 0.5 mg × 3 times/1 day, for 5 days) and chloramphenicol (vaginal tablet 100 mg × 1/1 day).Vaginal cleansing was performed.The patient was discharged five days after admission.At the time of this report, the patient outcome was not reported.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; 51 and 74-80 new york avenue; framingham MA 01701
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 16665831
• MDR Text Key: 312542880
• Report Number: 1416980-2023-01488
• Device Sequence Number: 1
• Product Code: MCN
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 638005
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2023
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female