MAUDE Adverse Event Report: COVIDIEN DOVER; TRAY, CATHETERIZATION, STERILE URETHRAL, WITH OR WITHOUT CATHETER

Model Number 2018

Device Problem Deflation Problem (1149)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 04/27/2018

Event Type  Injury  

Manufacturer Narrative

Submit date: 5/21/2018.The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.If information is provided in the future, a supplemental report will be issued.

Event Description

Customer reports: when attempting to remove the catheter balloon, the balloon did not deflate, even when trying to cut the valve.Surgical intervention was required to remove the balloon from the patient's bladder.

• Brand Name: DOVER
• Type of Device: TRAY, CATHETERIZATION, STERILE URETHRAL, WITH OR WITHOUT CATHETER
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 1113 cuidad; tijuana,na 22444 ; MX 22444
• Manufacturer (Section G): COVIDIEN; calle 9 sur no. 1113 cuidad; tijuana,na 22444 ; MX 22444
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 7531333
• MDR Text Key: 108856451
• Report Number: 9612030-2018-00094
• Device Sequence Number: 1
• Product Code: FCM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2018
• Device Catalogue Number: 2018
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/27/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention