FDA.reportPublic FDA data

MAUDE MDR 8259961

MDR report key
8259961
Report number
3007420694-2019-00018
Event key
0
Event type
3
Date received
2019-01-18
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. KINGA STOLINSKA
Address
KS. WAWRZYNIAKA 2 KOMORNIKI, 62-05 PL
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PARKER BATHBATH, HYDRO-MASSAGEARJO HOSPITAL EQUIPMENT ABILJAL14110-EUR Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-01-1801. O

Event Narratives#

N

Patient 1

(B)(4). ARJO REPRESENTATIVE EVALUATED THE DEVICE IN QUESTION. THE GAS STRUT HEAD WAS LOOSE BECAUSE OF THE ABSENCE OF A LOCKNUT. THE GAS STRUT HEAD WAS DISASSEMBLED AND THE DOOR WAS COMPLETELY FREE, SO IT WAS CLOSING HEAVY. THE BATHTUB WAS NOT REMOVED FROM USE BY THE CUSTOMER FACILITY DESPITE THE PROBLEM. THE DEFECTIVE PART WAS REPLACED BY THE ARJO REPRESENTATIVE. ADDITIONAL INFORMATION WILL BE PROVIDED WITHIN THE NEXT REPORT.

D

Patient 1

IT WAS REPORTED THAT DURING INSPECTION REQUESTED BY THE CUSTOMER FACILITY, THE ARJO QUALIFIED REPRESENTATIVE DETECTED THE DEFECT OF THE BATH'S DOOR GAS STRUT. THE MALFUNCTION RESULTED IN THE DOOR UNABLE TO REMAIN IN REQUIRED POSITION AND CLOSING FAST. THE BATHTUB WAS USED BY THE CUSTOMER DESPITE THE MALFUNCTION. NO INFORMATION REGARDING AN INJURY OCCURRENCE WAS PROVIDED.