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

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

Patient Problems Inflammation (1932); Pain (1994)

Event Date 08/13/2022

Event Type  Injury  

Event Description

It was reported that a patient underwent a hysterectomy in which adept adhesion reduction solution was used.The following day, the patient presented to the emergency room with pain and inflammation and was subsequently admitted to the hospital.Treatment for the events was not reported.Five days later, 600 ml of fluid was removed and sent for testing.It was reported the patient ¿felt much better after the fluid was removed¿.No additional information is available.

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.

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: ADEPT
• Type of Device: BARRIER, ABSORABLE, ADHESION
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - CASTELBAR; 28 moneen road; ni; castelbar ; EI
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 15418828
• MDR Text Key: 299867692
• Report Number: 1416980-2022-04813
• Device Sequence Number: 1
• Product Code: MCN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2022
• 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
• Date Manufacturer Received: 11/02/2022
• 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 Sex: Female