FDA.reportPublic FDA data

MAUDE MDR 8277199

MDR report key
8277199
Report number
1222304-2019-00001
Event key
0
Event type
3
Date of event
2018-12-23
Date received
2019-01-25
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#

Address
1 CUMMINGS POINT RD. STAMFORD,
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1CONAIRBIA SCALECONAIR CORPORATIONMNWWW52YY R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-01-2501. O

Event Narratives#

N

Patient 1

ON 1/25/2018 - WE HAVE RECEIVED THE DEVICE ON 1/23/2018 AND THE MANUFACTURERS INSPECTION WAS COMPLETE. BELOW IS THE MANUFACTURERS NARRATIVE; MANUFACTURERS NARRATIVE DURING THE PROCESS TO MAKE THE GLASS SHARD PROOF, OR SAFETY GLASS, THERE IS AN ANOMALY THAT IS SEEN ON VERY FEW FINISHED GLASS PARTS. THERE IS INTERNAL STRESS THAT IS SOMETIMES CREATED DURING THE HEAT PROCESS. THIS STRESS CAN NOT BE DETERMINED THROUGH NORMAL TESTING. DURING USE AT SPECIFIC TEMPERATURES THE STRESS BECOMES APPARENT THOUGH MAKING CONTACT BY EITHER STEPPING OR BANGING THE SCALE AGAINST SOMETHING HARD. SOMETIMES THE INTERNAL STRESS BREAKS THE GLASS WHEN NO EXTERNAL EVENT CAUSED IT. THE NUMBER OF EVENTS IS VERY LOW AND THE TECHNOLOGY SO FAR HAS NOT PROVIDED A SOLUTION TO PREVENT THIS ON ALL GLASS SCALES.

D

Patient 1

ON (B)(6) 2018 - THE CONSUMER CLAIMS THAT THE PRODUCT SHATTERED. WHILE CLEANING THE CONSUMER CUT HIS FINGER. MEDICAL ATTENTION WAS NOT RECEIVED.