MAUDE Adverse Event Report: CONVATEC CURE PRODUCTS; CATHETER, STRAIGHT

Model Number	HM16
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Fda registration number reporting site: 1049092 manufacturing site: 3005471919.
Event or Problem Description
End user reports unknown qty of catheters, "almost two dozen", sticking to packaging, when this first occurred 4-5 yrs ago.Additionally, he states the catheter tip area was sticking inside the catheter packaging.He said he always preps the catheter by bursting the sterile water packet to hydrate the catheter well and then goes to remove the catheter from package to use it.When he first noticed them sticking to the packaging near the tip after prepping the catheter (again, this occurred 4- 5 yrs ago and no prior complaint cases on file) he just jerked it out of the packaging and used it.Upon passing it through his urethra he said he has to always push it through his stricture and he said it felt like it cut him about 6-8 inches inside his urethra.When he pulled it out, he said because the tip had stuck to the bottom of the packaging the tip was also affected and it was sharp "like a knife blade." he said he had a lot of bleeding following that catheterization and bled for 3 days after that.He did go to his urologist at the time and just remembers being given a round of antibiotics for infection prevention before the bleeding finally stopped.

• Brand Name: CURE PRODUCTS
• Common Device Name: CATHETER, STRAIGHT
• Manufacturer (Section D): CONVATEC; 7815 national service road; suite 600; greensboro NC 27409
• Manufacturer (Section G): CONVATEC; 7815 national service road; suite 600; greensboro NC 27409
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC 27409 ; 3367062840
• MDR Report Key: 22288552
• Report Number: 1049092-2025-00188
• Device Sequence Number: 12980769
• Product Code: EZD
• UDI-Device Identifier: 00815947020321
• UDI-Public: 00815947020321
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 05/20/2025

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: HM16
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2025
• Initial Report FDA Received Date: 06/18/2025
• 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 Age: 79 YR
• Patient Sex: Male