MAUDE Adverse Event Report: CONVATEC INC Cure Catheter®; CATHETER, STRAIGHT

Model Number	510854
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Common device name: catheter, straight.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 or Problem Description
End user reports "urethral irritation as they felt sharp with insertion with use of qty "2 or 3" m18 catheters from 1 mu box back at the beginning of this year in "january or march", lot unknown.He states that they "felt sharp" only going in.This feeling was felt more part way in, not initially.He said he tried 2 or 3 others to make sure it wasn't just an issues with one and he said they all felt that way.He did not see anything abnormal or sharp on the catheter itself.He immediately discontinued use.He said the irritation did not last too long, no medical intervention sought.He did not get an infection but felt worried he may if he continued using them.He said he did apply lubricant to them prior to use.He said he uses the same additional lubricant on his regular catheters as well even though they are the hydrophilic bard magic 3s.He said these have never caused him irritation or pain going in.He currently uses his bard magic 3's." end user was advised "not use the m18s and he said he has already discontinued use." end user states "he caths 4 x a day for retention from his diagnosis cerebral palsy resulting in neurogenic bladder.He has been cathing since 1994.".

• Brand Name: Cure Catheter®
• Common Device Name: CATHETER, STRAIGHT
• Manufacturer (Section D): CONVATEC INC; 211 american avenue; greensboro NC
• Manufacturer (Section G): CONVATEC INC; 211 american avenue; greensboro NC
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC ; 3365424679
• MDR Report Key: 15275770
• Report Number: 1049092-2022-00319
• Device Sequence Number: 7020746
• Product Code: EZD
• UDI-Device Identifier: 00815947020055
• UDI-Public: 00815947020055
• Combination Product (Y/N): N
• PMA/510(K) Number: K072539
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/17/2022

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
• Operator of Device: Lay User/Patient
• Device Model Number: 510854
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/17/2022
• Initial Report FDA Received Date: 08/23/2022
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male