MAUDE Adverse Event Report: AMS; ARTIFICIAL BOWEL SPHINCTER

Model Number 11CM

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/10/2014

Event Type  malfunction  

Event Description

Recurrent cuff malfunction with artificial bowel sphincter.

• Type of Device: ARTIFICIAL BOWEL SPHINCTER
• Manufacturer (Section D): AMS; minnetonka 55343
• MDR Report Key: 3874183
• MDR Text Key: 4506751
• Report Number: MW5036601
• Device Sequence Number: 1
• Product Code: MIP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/10/2014

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 Expiration Date: 03/21/2018
• Device Model Number: 11CM
• Device Catalogue Number: 72401960
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/11/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 57 YR
• Patient Weight: 64