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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONVATEC INC L3C0600 - CURE PRODUCTS

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CONVATEC INC L3C0600 - CURE PRODUCTS Back to Search Results
Model Number 510816
Device Problem Material Too Soft/Flexible (4007)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/21/2021
Event Type  malfunction  
Manufacturer Narrative
Common device name: cure ultra® ready-to-use catheter for men.Based on the available information, this event is deemed to be a reportable malfunction.This complaint has been evaluated.No lot number is available.A detailed investigation or batch review cannot be conducted.Therefore, this evaluation will be closed.This issue will be monitored through the post market product monitoring review process.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.(b)(4).
 
Event Description
It was reported " that the stems aren't stiff enough." no harm was reported.
 
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Brand Name
L3C0600 - CURE PRODUCTS
Manufacturer (Section D)
CONVATEC INC
211 american avenue
greensboro NC
Manufacturer (Section G)
CONVATEC INC
211 american avenue
greensboro NC
Manufacturer Contact
pamela meadows
211 american avenue
greensboro, NC 
3365424681
MDR Report Key12744695
MDR Text Key282629863
Report Number1049092-2021-00118
Device Sequence Number1
Product Code OHR
UDI-Device Identifier00815947021076
UDI-Public00815947021076
Combination Product (y/n)N
PMA/PMN Number
K072539
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 10/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number510816
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received10/27/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient SexMale
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