FDA.reportPublic FDA data

MAUDE MDR 9737698

MDR report key
9737698
Report number
9618003-2020-02354
Event key
0
Event type
3
Date received
2020-02-21
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. 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
1COLOHESIVE+ PCH CLD STD CLR 32MM(1X30)ESPOUCH, COLOSTOMYCONVATEC DOMINICAN REPUBLIC INCEZQ4011119A01580N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-02-210

Event Narratives#

N

Patient 1

DEVICE 42 OF 60. (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 THE STARTER HOLE WAS OFF-CENTERED IN WAFERS. THE PRODUCTS WERE USED. THERE WAS NO HARM REPORTED AND A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.