MAUDE Adverse Event Report: COLOPLAST A/S SILIC FOLEY CATH 5/10ML /5; SILICONE FOLEY CATHETER

Model Number AA61141002

Device Problem Output Problem (3005)

Patient Problems Urinary Retention (2119); Abdominal Distention (2601)

Event Date 03/15/2017

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 of 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, indwelling of a catheter without difficulty.Three (3) hours later, no diuresis, distended abomus.Presence of a semi-transparent cap in the catheter lumen.

• Brand Name: SILIC FOLEY CATH 5/10ML /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-can[?]da, 24206 ; FR 24206
• Manufacturer Contact: christine buckvold
• MDR Report Key: 6457898
• MDR Text Key: 71891178
• Report Number: 9610711-2017-00015
• 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
• Report Date: 04/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AA61141002
• Device Catalogue Number: AA61141002
• Device Lot Number: 5102835
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/30/2017
• Initial Date FDA Received: 04/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other