MAUDE Adverse Event Report: COLOPLAST A/S SPEEDICATH COMPACT CH10 FEMALE; INTERMITTENT CATHETER

Model Number 2858001624

Device Problem Detachment Of Device Component (1104)

Patient Problems Unspecified Infection (1930); Irritation (1941); Pain (1994); Burning Sensation (2146); Hematuria (2558); No Code Available (3191)

Event Date 08/25/2017

Event Type  Injury  

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 of conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.

Event Description

Patient was instructed to do cic due to an atonic bladder.She received instructions by the hospital nurse and managed to cath herself at home few times.On (b)(6) 2017 she inserted the speedicath #10 and when pulling it out, the top part of the catheter got detached from the bottom part and stayed inside her bladder.The following day the detached part was taken out in the operating room under sedation.Patient was bending and pulled the catheter harder than it should and said it might be that before the incident, she had pulled too hard so top and bottom part detached.Patient does have bloody urine since the incidence however she said she was having a uti at the time.She has ongoing uti infections.Till now she has the bladder infection and suffers from constant pain in her lower abdomen aside pain during urination.Her genitalia is irritated with burning sensation.

• Brand Name: SPEEDICATH COMPACT CH10 FEMALE
• Type of Device: INTERMITTENT CATHETER
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST A/S NYIRBATOR; coloplast utca 2; nyirbator, 4300 ; HU 4300
• Manufacturer Contact: christine buckvold ; 1601 west river road north; minneapolis, MN 55411 ; 6123024982
• MDR Report Key: 6893903
• MDR Text Key: 87352285
• Report Number: 3006606901-2017-00018
• Device Sequence Number: 1
• Product Code: GBM
• Combination Product (y/n): N
• PMA/PMN Number: K023254
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial
• Report Date: 09/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 2858001624
• Device Catalogue Number: 2858001624
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 21 YR