MAUDE Adverse Event Report: UNKNOWN UNKNOWN; CLIP, IMPLANTABLE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Bowel Perforation (2668)

Event Date 05/09/2019

Event Type  Injury  

Event Description

Had an emr.Clips were placed on outside of colon.Pain was so intense went to emergency room (er).Had cat scan which showed perforated bowel.Admitted, had colon restriction rt hemi colectomy.Fda safety report id # (b)(4).

• Brand Name: UNKNOWN
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 8646113
• MDR Text Key: 146463036
• Report Number: MW5086933
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention; Disability
• Patient Age: 66 YR
• Patient Weight: 61