MAUDE Adverse Event Report: COLOPLAST A/S SPEEDICATH COMPACT EVE CH10; SILICONE FOLEY CATHETER

Model Number 2811001001

Device Problem Bent (1059)

Patient Problem Hematuria (2558)

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

According to the information received, at opening the catheter had a little bend, after catheterization she had traces of blood in urine.

Manufacturer Narrative

Three samples arrived.They had all been opened but not correctly as the two rings were not visible.The catheters were not bent but slightly curved which is ok.No other complaints was registered with this lot number.We have no indication that indicates that the problem is caused by a product fault.

• Brand Name: SPEEDICATH COMPACT EVE CH10
• Type of Device: SILICONE FOLEY CATHETER
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, da 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST A/S MANUFACTURING FRANCE SAS; 9 avenue edmond rostand; sarlat la caneda, 24206 ; DA 24206
• Manufacturer Contact: christine buckvold ; 1601 west river road north; minneapolis, MN 55411 ; 6123024982
• MDR Report Key: 5424498
• MDR Text Key: 37891135
• Report Number: 9610711-2016-00008
• Device Sequence Number: 1
• Product Code: GBM
• Combination Product (y/n): N
• PMA/PMN Number: K150935
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 03/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 2811001001
• Device Catalogue Number: 2811001001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2016
• Date Manufacturer Received: 01/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other