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

Model Number	AA61061002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematuria (2558); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/02/2021
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.(b)(4).
Event or Problem Description
According to the available information, a full-term neonate was catheterized with mandrel in place.The catheter was easily assembled and the balloon was inflated.On removal of the mandrel, the patient experienced transitory hematuria and spontaneous diuresis.The catheter was removed and the patient was treated with an injection of exacyl.

• 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: 11727484
• Report Number: 9610711-2021-00036
• Device Sequence Number: 3138648
• Product Code: EZL
• UDI-Device Identifier: 03600040126844
• UDI-Public: 03600040126844
• Combination Product (Y/N): N
• PMA/510(K) Number: K013174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/26/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: AA61061002
• Device Catalogue Number: AA6106
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/16/2021
• Initial Report FDA Received Date: 04/26/2021
• 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