FDA.reportPublic FDA data

MAUDE MDR 4262480

MDR report key
4262480
Report number
3003197958-2014-00001
Event key
0
Event type
3
Date of event
2014-05-23
Date received
2014-11-19
Adverse event
0
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Address
2012 W. COLLEGE AVE. NORMAL IL 61761 US
Report source
D
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SEAL RITE MASK WITH ONE WAY VALVEENTER MEDICAL CORPBSJ12014015* Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-11-190

Event Narratives#

D

Patient 1

THE ISSUES WITH THE SUSPECT MEDICAL DEVICE, SEAL RITE MASKS, WERE INITIALLY REPORTED TO THE IMPORTER OF THIS DEVICE, THE (B)(4), ON (B)(6) 2014 BY A CUSTOMER WHO PURCHASED AND USED THIS MASK IN A (B)(4) TRAINING COURSE. BELOW ARE THE INITIAL REPORTER'S OWN WORDS: "I PURCHASED THE SEAL RITE MASKS TO REPLACE MY EXISTING SEAL EASY MASKS. I USED THEM THIS PAST WEEKEND IN LIFEGUARD TRAINING AND WAS VERY DISAPPOINTED. IMMEDIATELY THE MASKS BEGAN TO COME APART, WOULD NOT STAY INFLATED, THE VALVE TO ADJUST AIR CAME APART ON MANY MASKS, WATER SEEPED INTO THE MASK AND SOME JUST LEAKED AIR CONSTANTLY." (B)(4) IMMEDIATELY STOPPED SELLING THESE MASKS AND INFORMED THEIR CONTRACT MFR ((B)(4) OF THE ISSUES ON 05/24/2014. (B)(4) DID THEIR BEST TO RECALL THE DEFECTIVE MEDICAL DEVICES SOLD. (B)(4) AND (B)(4) WORKED CLOSELY TO RECTIFY THESE DEFECTS. SINCE EARLY JUNE, 2014, ALL THE DEFECTS HAVE BEEN RECTIFIED. PLEASE REFERENCE MW5036511 AND MFR# 3006157842-2014-00001.