FDA.reportPublic FDA data

MAUDE MDR 5099013

MDR report key
5099013
Report number
3005945907-2015-00003
Event key
0
Event type
3
Date of event
2015-08-24
Date received
2015-09-23
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
BRIAN SCHMIDT
Address
1601 WEST RIVER ROAD NORTH MINNEAPOLIS MN 55411 US
Phone
612-612-6123
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1FREEDOM SELF-CATH NELATON CH1MALE EXTERNAL CATHETERCOLOPLAST A/SEXJ50452014005045201400R Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-09-2301. R

Event Narratives#

N

Patient 1

WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURENCE. SHOULD ADDITIONAL FACTS PROMPT US TO ALTER OR SUPPLEMENT ANY INFORMATION OR CONCLUSIONS CONTAINED IN THE ORIGINAL MDR OR IN ANY PRIOR SUPPLEMENTAL REPORTS, A FOLLOW-UP REPORT WILL BE SUBMITTED.

D

Patient 1

ACCORDING TO THE INFORMATION RECEIVED, END USER HAS BEEN CATHING SINCE HE WAS (B)(6) AND WHEN HE PUTS THE LUBRICATION ON THE CATH AND INSERTS NOTHING COMES OUT. HE THEN REMOVES THE CATHETER AND THEN REALIZES THERE ARE NO EYELETS. EU HAS ABOUT 50 CATHS THAT DON'T HAVE EYELETS THAT HE HAS USED. END USER GETS THEM FROM J&B AND WILL GET HIS NEXT SHIPMENT THE FIRST OF THE MONTH OF 260 AND CATHS 6-10 TIMES A DAY.