FDA Adverse Event Malfunction Summary report: N

MINI ONE BALLOON BUTTON

MDR report key: 12094757 · Received June 30, 2021

Report

Report Number: 1526012-2021-00015
Event Type: Malfunction
Date Received: June 30, 2021
Date of Event: May 19, 2021
Report Date: June 30, 2021
Manufacturer: APPLIED MEDICAL TECHNOLOGY, INC.
Product Code: KNT
PMA / PMN Number: K161413
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CT, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

THIS REPORT IS A RESPONSE TO REPORT # (B)(4) WHICH WAS RECEIVED BY AMT FROM THE FDA ON 06/01/2021. BASED ON THE PROVIDED INFORMATION, THE INCIDENT IS NOT A REPORTABLE EVENT PER 21 CFR SECTION 803. THERE WAS NO DEATH. THERE WAS NO SERIOUS INJURY, AS DEFINED BY THE FDA. THIS WAS NOT LIFE-THREATENING, NOR DID THIS RESULT IN PERMANENT IMPAIRMENT OR NECESSITATE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT. AMT WORKED WITH THE REPORTER AND OBTAINED THE DEVICE FOR EXAMINATION ON 6/15/2021. THE DEVICE WAS EXAMINED AND THERE WAS NO INDICATION THAT A MANUFACTURING DEFECT CAUSED THE FAILURE OF THE DEVICE. A DEVICE HISTORY REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND FOR THE RELATED LOT. COMPLAINT # (B)(4) WAS ASSIGNED TO THIS REPORT. THE COMPLAINT HAS BEEN LOGGED AND WILL BE USED IN OUR COMPLAINT TRENDING PROCESS FOR FUTURE PRODUCT ENHANCEMENTS.

Description of Event or Problem · 1

THIS REPORT IS IN RESPONSE TO UF/IMPORTER REPORT#: (B)(4). THE ORIGINAL REPORT INDICATED "G-TUBE PLACED VIA SURGERY- ONE WEEK POST PLACEMENT PATIENT SEEN IN ED WITH QUESTIONABLE NON-FUNCTIONING G-TUBE. UPON REMOVAL AND PLACEMENT, HOLE NOTED IN BALLOON."

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
993957	MINI ONE BALLOON BUTTON	TUBES, GASTROINTESTINAL (AND ACCESSORIES)	KNT	APPLIED MEDICAL TECHNOLOGY, INC.	M1-5-1410	210104-4444

Patients

Seq	Age	Sex	Outcome	Treatment
1