FDA.reportPublic FDA data

MAUDE MDR 9392601

MDR report key
9392601
Report number
9618003-2019-13217
Event key
0
Event type
3
Date of event
2019-10-30
Date received
2019-11-30
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
Phone
336-336-3365
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1NATURAPROTECTOR, OSTOMYCONVATEC DOMINICAN REPUBLIC INCEXE4045929A03366N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-11-300

Event Narratives#

N

Patient 1

(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. DEVICE 416 OF 1313. (B)(4).

D

Patient 1

IT WAS REPORTED BY THE RETAILER/DISTRIBUTOR THAT " THE HOLE OF WFR IS NOT IN CENTER". THE PRODUCT WAS NOT USED, NO HARM REPORTED. PHOTOGRAPHS WERE RECEIVED FROM THE COMPLAINANT DEPICTING THE REPORTED COMPLAINT ISSUE. STOCK WAS REVIEWED AND COUNTED BY THE DISTRIBUTOR.