FDA.reportPublic FDA data

MAUDE MDR 8511384

MDR report key
8511384
Report number
2518435-2019-00001
Event key
0
Event type
3
Date of event
2018-01-01
Date received
2019-04-12
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
3
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
STEVE MILLER
Address
12800 WEST LITTLE YORK ROAD HOUSTON TX 77041 US
Phone
713-713-7138
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SULFUR HEXAFLUORIDESULFUR HEXAFLUORIDEAIRGAS USALPOTR9088722125Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-04-1201. O

Event Narratives#

N

Patient 1

EVENT: CUSTOMER REPORTED TO DISTRIBUTOR THAT THEY HAD BEEN USING A GAS CYLINDER OF SULFUR HEXAFLUORIDE SINCE (B)(6) 2017 WITH NO ISSUES BUT TWO RECENT CASES INVOLVING RETINA RE-ATTACHMENT HAD RE-DETACHED. NO FURTHER INFORMATION WAS PROVIDED NOT WERE ADDITIONAL REPORTS PROVIDED THAT PATIENTS EVENTUALLY HAD SUCCESSFUL REATTACHMENT OR NOT. NO INDIVIDUAL PATIENT INFORMATION IS KNOWN SUCH AS AGE, SEX, ETC.. ON 2/27/2018, THE DISTRIBUTOR REPORTED THE CASE TO MANUFACTURER. THE ACTUAL DATE OF THE PATIENT EVENTS IS UNKNOWN OTHER THAN THAT THEY OCCURRED ON THE SAME DAY. THE PRODUCT WAS RETURNED TO MANUFACTURER. MANUFACTURER CONDUCTED A REVIEW OF THE BATCH PRODUCT RECORD AND DISCOVERED NO ISSUES. MANUFACTURER ALSO RE-ANALYZED THE CYLINDER OF GAS AND THE PRODUCT MET THE ORIGINAL SPECIFICATION.

D

Patient 1

EVENT: CASE 1 OF 2. CUSTOMER REPORTED TO DISTRIBUTOR THAT THEY HAD BEEN USING A GAS CYLINDER OF SULFUR HEXAFLUORIDE SINCE (B)(6) 2017 WITH NO ISSUES BUT TWO RECENT CASES INVOLVING RETINA RE-ATTACHMENT HAD RE-DETACHED. NO FURTHER INFORMATION WAS PROVIDED NOR WERE ADDITIONAL REPORTS PROVIDED THAT PATIENTS EVENTUALLY HAD SUCCESSFUL REATTACHMENT OR NOT. NO INDIVIDUAL PATIENT INFORMATION IS KNOWN SUCH AS AGE, SEX, ETC.. ON 2/27/2018, THE DISTRIBUTOR REPORTED THE CASE. THE ACTUAL DATE OF THE PATIENT EVENTS IS UNKNOWN OTHER THAN THAT THEY OCCURRED ON THE SAME DAY. THE PRODUCT WAS RETURNED TO MANUFACTURER. MANUFACTURER CONDUCTED A REVIEW OF THE BATCH PRODUCT RECORD AND DISCOVERED NO ISSUES. MANUFACTURER ALSO RE-ANALYZED THE CYLINDER OF GAS AND THE PRODUCT MET THE ORIGINAL SPECIFICATION.