MAUDE Adverse Event Report: FOLYSIL CATHETER; CATHETER, RETENTION TYPE, BALLOON

Model Number AA61141002

Device Problem Deflation Problem (1149)

Patient Problems Pain (1994); Genital Bleeding (4507); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device received for analysis did not match the reported device involved in this complaint.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 information 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 Description

According to the available information, the balloon did not fully deflate during withdrawal and created a pleated bulge that increased the diameter and "created some relief." the patient experienced pain during withdrawal "linked by the grip" and bleeding of the "internal hole." triggering of autonomic hyper reflexia was also reported.It was noted "use of a lot of xylocaine gel" and that the cause of the event was the product.

Manufacturer Narrative

Correction: g1 manufacturing site.

• Brand Name: FOLYSIL CATHETER
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• MDR Report Key: 12546802
• MDR Text Key: 273779202
• Report Number: 9610711-2021-00072
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 03600040127360
• UDI-Public: 03600040127360
• Combination Product (y/n): N
• PMA/PMN Number: K013174
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 10/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: AA61141002
• Device Catalogue Number: AA6114
• Device Lot Number: 7810336
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other