FDA.reportPublic FDA data

MAUDE MDR 6810939

MDR report key
6810939
Report number
3007225376-2017-00002
Event key
0
Event type
3
Date received
2017-08-22
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MRS. KRISTIE SOTO
Address
2485 CORPORATE CIRCLE SUITE 2 EAST TROY WI 53120 US
Phone
262-262-2626
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1REN? VOICESYSTEM, VOCAL CORD MEDIALIZATIONCYTOPHIL, INC.MIX08-015-04-V04P508-00002N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-08-220

Event Narratives#

N

Patient 1

THE PHYSICIAN WAS ABLE TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH THE MATERIAL PROVIDED IN THE SYRINGE. THE DEVICE WAS NOT RETURNED TO CYTOPHIL FOR EVALUATION. ADDITIONAL INFORMATION REGARDING THE REPORTED COMPLAINT IS BEING REQUESTED FROM THE PHYSICIAN. THE INVESTIGATION IS ONGOING; A SUPPLEMENTAL REPORT WILL BE PROVIDED.

D

Patient 1

THE PHYSICIAN REPORTED THAT UPON OPENING THE RENU VOICE, IT WAS DISCOVERED THAT THE PRODUCT SYRINGE WAS UNDER-FILLED. HE ESTIMATED THAT THE SYRINGE CONTAINED APPROXIMATELY 50% VOLUME. THE PHYSICIAN ALSO INDICATED THAT THERE WAS NO EVIDENCE OF PRODUCT LEAKAGE WITHIN THE STERILE POUCH. THE PHYSICIAN STATED THAT THERE WAS NO PATIENT IMPACT AS THE VOLUME IN THE SYRINGE WAS SUFFICIENT TO SUCCESSFULLY COMPLETE THE PROCEDURE. (B)(4).