AQUAPLAST PELLETS RT- 7001 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-12-22 for AQUAPLAST PELLETS RT- 7001 * manufactured by Qfix.

Event Text Entries

[15821299] Aquaplast beads used to create custom fitting bolus for filling bilateral nasal cavity/vestibules for nasal septum squamous cell ca. When it hardened, the external tips of material fused, creating a semicircular "ring: of aquaplast that could not be readily removed from the patient's nasal cavity, as the space between the internal part of the aquaplast "ring" was too narrow pass around the inferior tip of nasal septum. The patient required an otolaryngologist to divide the fused external bridge between bolus material in left and right nasal cavities to remove from the patient's nose.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	4384694
MDR Report Key	4384694
Date Received	2014-12-22
Date of Report	2014-12-22
Date of Event	2014-11-13
Report Date	2014-12-22
Date Reported to FDA	2014-12-22
Date Reported to Mfgr	2015-01-06
Date Added to Maude	2015-01-06
Event Key	0
Report Source Code	User Facility report
Manufacturer Link	N
Number of Patients in Event	0
Adverse Event Flag	3
Product Problem Flag	3
Reprocessed and Reused Flag	0
Reporter Occupation	RISK MANAGER
Health Professional	3
Initial Report to FDA	3
Report to FDA	3
Event Location	3
Single Use	0
Previous Use Code	0
Event Type	3
Type of Report	3

Device Details

Brand Name	AQUAPLAST PELLETS
Generic Name	SPLINT, NASAL
Product Code	EPP
Date Received	2014-12-22
Model Number	RT- 7001
Catalog Number	*
Lot Number	*
ID Number	*
Operator	PHYSICIAN
Device Availability	N
Device Age	*
Device Sequence No	1
Device Event Key	0
Manufacturer	QFIX
Manufacturer Address	440 CHURCH ROAD AVONDALE PA 19311 US 19311

Patients

Patient Number	Treatment	Outcome	Date
1	0		2014-12-22
2	0		2014-12-22