MAUDE Adverse Event Report: COLOPLAST A/S SILIC FOLEY CATH 5/15ML /5; SILICONE FOLEY CATHETER

Model Number AA61161002

Device Problem Material Separation (1562)

Patient Problems Pain (1994); Discomfort (2330); Device Embedded In Tissue or Plaque (3165)

Event Date 10/07/2015

Event Type  malfunction  

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 Description

According to the information received, when the catheter was inserted, the patient felt pain and discomfort.Because of this, the catheter was removed.Once the catheter was extracted, it was without the tip which was still inside the patient.This required specific medical intervention and the accident was reported to the ministry of health.

• Brand Name: SILIC FOLEY CATH 5/15ML /5
• Type of Device: SILICONE FOLEY CATHETER
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST A/S MANUFACTURING FRANCE SAS; 9 avenue edmond rostand; sarlat la canéda, 24206 ; FR 24206
• Manufacturer Contact: christine buckvold ; 1601 west river road north; minneapolis, MN 55411 ; 6123024982
• MDR Report Key: 5208466
• MDR Text Key: 30856666
• Report Number: 9610711-2015-00035
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 03600040127490
• UDI-Public: 03600040127490
• Combination Product (y/n): N
• PMA/PMN Number: K013174
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial
• Report Date: 11/02/2015

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
• Device Operator: Lay User/Patient
• Device Model Number: AA61161002
• Device Catalogue Number: AA61161002
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/07/2015
• Initial Date FDA Received: 11/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention