• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: Medline Industries, LP CURAD; BANDAGE,FABRIC,CURAD,FNG/KNCKL, 20CT

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

Medline Industries, LP CURAD; BANDAGE,FABRIC,CURAD,FNG/KNCKL, 20CT Back to Search Results
Catalog Number CUR45246RB
Medical Device Problem Code Loss of or Failure to Bond (1068)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 01/25/2023
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that curad bandages are not sticky.
 
Additional Manufacturer Narrative
Customer (b)(6) called because curad bandages are not sticky.Sample/photo provided: none; complaint could not be confirmed as there were no samples or pictures received.Investigation results: not confirmed; root cause: not confirmed/no sample received.Without a sample received it is difficult to determine a true root cause for the reported issue, and should the sample/detailed picture become available, the complaint will be reopened and investigated accordingly.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CURAD
Common Device Name
BANDAGE,FABRIC,CURAD,FNG/KNCKL, 20CT
Manufacturer (Section D)
Medline Industries, LP
three lakes drive
northfield IL 60093 -275
Manufacturer Contact
diana arizmendi
three lakes drive
northfield, IL 60093--275
MDR Report Key50773691
Report Number1417592-2026-40612
Device Sequence Number18571298
Product Code KGX
UDI-Device Identifier40080196320739
UDI-Public40080196320739
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source Company Representative
Type of Report Initial
Report Date (Section B) 09/11/2026
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Catalogue NumberCUR45246RB
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/25/2023
Initial Report FDA Received Date09/15/2026
Was Device Evaluated by Manufacturer? (Y/N) No
Is the Device Labeled for Single Use? (Y/N) Yes
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)
No
Patient Sequence Number1
Patient SexUnknown
-
-