UNIFIX ANORECTAL BALLOON HOLDER A86-4400-10

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-11-14 for UNIFIX ANORECTAL BALLOON HOLDER A86-4400-10 manufactured by Sandhill Scientific, Inc..

Event Text Entries

[17611519] The band holder did not hold the balloon on the anorectal probe when the probe was removed. The balloon was lost within the patient's colon. A sigmoidoscopy was performed to remove the balloon.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2023374-2013-00001
• MDR Report Key: 3535776
• Report Source: 05
• Date Received: 2013-11-14
• Date of Report: 2013-11-14
• Date of Event: 2013-10-15
• Date Mfgr Received: 2013-10-15
• Date Added to Maude: 2014-01-13
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Manufacturer Contact: GUY HARRIS
• Manufacturer Street: 9150 COMMERCE CENTER CIR.,#500
• Manufacturer City: HIGHLANDS RANCH CO 80129
• Manufacturer Country: US
• Manufacturer Postal: 80129
• Manufacturer Phone: 3034707020
• Single Use: 3
• Remedial Action: OT
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: UNIFIX ANORECTAL BALLOON HOLDER
• Generic Name: UNIFIX ANORECTAL BALLOON HOLDER
• Product Code: EXX
• Date Received: 2013-11-14
• Model Number: A86-4400-10
• Catalog Number: A86-4400-10
• Lot Number: NA
• ID Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: SANDHILL SCIENTIFIC, INC.
• Manufacturer Address: HIGHLANDS RANCH CO 80129 US 80129

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2013-11-14