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

Catalog Number 1501571

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

Patient Problem Reaction (2414)

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 that a patient underwent an unspecified procedure in which adept adhesion reduction solution was used.It was reported that after use of the product, the patient experienced an accumulation of fluids within the abdominal cavity, further specified as an allergic reaction.At the time of this report no further detail was provided regarding any treatment, interventions for the event or the patient¿s outcome.No additional information is available.

• Brand Name: ADEPT
• Type of Device: BARRIER, ABSORABLE, ADHESION
• Manufacturer (Section D): BAXTER HEALTHCARE - CASTLEBAR; 28 moneen road
• Manufacturer (Section G): BAXTER HEALTHCARE - CASTLEBAR; 28 moneen road; castelbar ; EI
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 8784725
• MDR Text Key: 150875535
• Report Number: 1416980-2019-03741
• Device Sequence Number: 1
• Product Code: MCN
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/12/2019

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
• Device Catalogue Number: 1501571
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/18/2019
• Initial Date FDA Received: 07/12/2019
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other