FDA.reportPublic FDA data

MAUDE MDR 7531331

MDR report key
7531331
Report number
1222074-2018-00141
Event key
0
Event type
3
Date of event
2015-11-30
Date received
2018-05-21
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 LAURA SMITH
Address
10 CONTINENTAL DR BLDG 1 EXETER NH 03833 US
Phone
603-603-6037
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1BACKFLUSH INSTRUMENT WITH DIATHERMY, INCL. ACTIVE ASPIRATION. (23 GAUGE / 0.6 MMBACKFLUSH INSTRUMENT WITH DIATHERMY, INCL. ACTIVE ASPIRATION. (23 GAUGE / 0.6 MMDUTCH OPTHALMIC RESEARCH CENTER BVHQR1281.BTD052000371247Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-05-210

Event Narratives#

N

Patient 1

THERE IS FOREIGN MATERIAL ATTACHED ON THE SHAFT PART. THE INVESTIGATION SHOWED THAT THE FOREIGN OBJECT ON THE SHAFT IS GLUE. THIS WILL BE REVIEWED WITH THE PRODUCTION DEPARTMENT TO FIND OUT HOW THIS HAS ESCAPED THE ATTENTION OF THE QUALITY CONTROL. DURING THE RETROSPECTIVE REVIEW, AND AS PER THE COMPLAINT DESCRIPTION, FOREIGN MATERIAL MAY LEAD TO SERIOUS HARM TO PATIENT, HENCE CONCLUDED AS REPORTABLE. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A VOLUNTARY RETROSPECTIVE REVIEW OF ALL COMPLAINTS SINCE 2015 BY THE MANUFACTURER (DUTCH OPHTHALMIC RESEARCH CENTRE (B)(4)). DETAILS OF THIS ACTIVITY WERE DISCUSSED WITH CDRH OFFICE OF COMPLIANCE ((B)(6)) DURING A TELE-CONFERENCE ON (B)(6) 2017. NO INFORMATION REASONABLY SUGGESTS ANYONE WAS HARMED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. THIS COMPLAINT HAS NOW BEEN CLOSED.

D

Patient 1

THERE IS FOREIGN MATERIAL ATTACHED ON THE SHAFT PART. NO REPORT OF INJURY. ALL INFORMATION HAS BEEN DISCLOSED.