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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION ADEPT; BARRIER, ABSORABLE, ADHESION
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BAXTER HEALTHCARE CORPORATION ADEPT; BARRIER, ABSORABLE, ADHESION Back to Search Results
Catalog Number 1501573
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Injury (2348)
Event Type  Injury  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that a patient underwent a laparotomy plus adhesion lysis procedure in which adept adhesion reduction solution was used.A total of 300ml of adept was used.It was reported that ¿fluid still in pelvis¿.It was reported the patient experienced a post op ileus.It was reported the patient will require aspiration to remove the fluid.It was reported the patient remained hospitalized for the event.At the time of this report, the patient outcome was not reported.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.
 
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Brand Name
ADEPT
Type of Device
BARRIER, ABSORABLE, ADHESION
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
MDR Report Key11088166
MDR Text Key224081167
Report Number1416980-2020-08135
Device Sequence Number1
Product Code MCN
Combination Product (y/n)Y
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 01/25/2021
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
Device Catalogue Number1501573
Device Lot NumberASKU
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/07/2020
Initial Date FDA Received12/29/2020
Supplement Dates Manufacturer Received01/20/2021
Supplement Dates FDA Received01/25/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age71 YR
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