MAUDE Adverse Event Report: CONVATEC INC L3C0600 - CURE PRODUCTS

Model Number	510826
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Urinary Tract Infection (2120)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Common device name: catheter, urological.Based on the available information, this event is deemed to be a serious injury.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 "pain and burning in her urethra and rectum after use of t10 catheters from lubricant that all "smelled like alcohol" from her newest shipment." on (b)(6) 2022 consumer had reported burning after use of the ultra10 catheters which was captured in a separate complaint case.She said she was then sent a new shipment of her usual t10 catheters and she noted that the catheters lubricant had the same "alcohol smell" as the ultra10s had prior to use and caused her burning after cathing, stating it felt like the newer t10s "set her on fire".She said she still now , a week and half later, has burning in urethra.She has stopped cathing and the burning is still present today, however, less than last week.She feels like she is leaking more urine has more frequency to void small amounts of urine as well, denies fevers.She has been trying to drink more water and less soda which has been helping.She said the burning also migrated to her rectum and causing burning and itching and "she can barely sit down." she thinks something has changed in the lubricant, noted by the alcohol smell, that caused her to have this reaction.She said nothing on the outside packaging or with the catheter looks odd, they are all sealed as before.She was always used to using t10 catheters for a very long time, they never caused her itching, burning or discomfort.She said the "t10 never smelled in this way, like alcohol, before.She did say she had a uti last month, her only symptom was that she felt like she could not void, her last day of taking antibiotics was (b)(6) she had marked on her calendar but she does not get utis often.She said she did get her urine checked by her md and an antibiotic was prescribed which helped her symptoms at that time.It was only shortly after she had these catheters that caused this burning after use that the lubricant had this alcohol smell.She said the only allergies she is aware of is to antibiotics, however, she could not relay to me which ones as she has allergies to many." end user was advised to discontinue use of catheters that had this "alcohol smell" she is describing, which she stated she already has.

• 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 ; 7815 national service road; suite 600; greensboro, NC ; 3365424679
• MDR Report Key: 15051176
• Report Number: 1049092-2022-00310
• Device Sequence Number: 11958076
• Product Code: GBM
• UDI-Device Identifier: 00815947020376
• UDI-Public: 00815947020376
• 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): 07/08/2022

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 Expiration Date: 08/28/2026
• Device Model Number: 510826
• Device Lot Number: 210923-2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/08/2022
• Initial Report FDA Received Date: 07/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2021
• 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: Female