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

Model Number	AA63121002
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	05/28/2016
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 of 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 catheter has been pulled off by force by the patient, how the catheter is not meant to be used.Catheter has been inserted into a stroke patient (patient is restless , no sensation of illness).Later, patient has pulled off the catheter.Catheter has broken in half and approximately half of the catheter has stayed inside the patient.Patient has been sent to a hospital for an operation to take the catheter out.

• Brand Name: FOLYSIL TIEMANN CATH 5/15ML
• Common Device Name: SILICONE FOLEY CATHETER
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, da 3050 ; DA 3050
• MDR Report Key: 5873247
• Report Number: 9610711-2016-00020
• Device Sequence Number: 1504045
• Product Code: EZL
• UDI-Device Identifier: 03600040128510
• UDI-Public: 03600040128510
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K013174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/12/2016

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: Lay User/Patient
• Device Model Number: AA63121002
• Device Catalogue Number: AA63121002
• Device Lot Number: 4397047
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2016
• Initial Report FDA Received Date: 08/12/2016
• 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: Other