FDA.reportPublic FDA data

MAUDE MDR 7232485

MDR report key
7232485
Report number
1000317571-2018-00019
Event key
0
Event type
3
Date received
2018-01-31
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. JEANETTE JOHNSON
Address
7900 TRIAD CENTER DRIVE SUITE 400 GREENSBORO NC 27409 US
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1RELEASE AGENTSOLVENT, ADHESIVE TAPEKOXTR 102T1540N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-01-310

Event Narratives#

N

Patient 1

PRODUCT NAME: NILTAC WIPE TR102 (1X30 PACK). (B)(6). BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

D

Patient 1

IT WAS REPORTED THAT SOME OF THE WIPES ARE STUCK IN THE PACKAGE THAT ENCLOSES THE WIPES. NO PHOTOS PROVIDED. NO FURTHER INFORMATION WAS AVAILABLE.