MAUDE Adverse Event Report: COLOPLAST A/S FOLYSIL CATHETER; CATHETER, RETENTION TYPE, BALLOON

Model Number	AA63161002
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.
Event or Problem Description
According to the available information, the patient experienced four catheter bursts.The patient had been self-inserting foley catheters for five years.He utilized a prefilled 15cc syring for inflation, and a statlock to hold the catheter in place.The catheters burst after less than 1 day in place.The patient stated he had not visited the doctor or emergency room for any treatment, but on all four occasions, it appeared all the pieces came out.The patient noted he had experienced bladder infections as a result of the bursts because the sterile water from the balloon entered his bladder.The patient was not experiencing any additional complications at the time this information was reported.All four catheters that burst had the same lot number.

• Brand Name: FOLYSIL CATHETER
• Common Device Name: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• MDR Report Key: 11117988
• Report Number: 9610711-2021-00003
• Device Sequence Number: 3923202
• Product Code: EZL
• UDI-Device Identifier: 03600040128770
• UDI-Public: 03600040128770
• Combination Product (Y/N): N
• PMA/510(K) Number: K013174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/29/2025
• Device Model Number: AA63161002
• Device Catalogue Number: AA6316
• Device Lot Number: 7372058
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/07/2020
• Initial Report FDA Received Date: 01/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention