FDA.reportPublic FDA data

MAUDE MDR 9652769

MDR report key
9652769
Report number
1018233-2020-00650
Event key
0
Event type
3
Date received
2020-01-31
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
3
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
YONIC ANDERSON
Address
8195 INDUSTRIAL BLVD COVINGTON GA 30014 US
Phone
770-770-7707
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ROCHESTER MEC SPIRIT SHEATH STYLE 3 WIDEBAND 32MM 30BXMECC.R. BARD, INC. (COVINGTON) -1018233NNX3930339303UNKR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-01-310

Event Narratives#

N

Patient 1

THE REPORTED EVENT WAS INCONCLUSIVE, AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. HOWEVER, A POTENTIAL FAILURE MODE COULD BE ?DEVICE IS DIFFICULT TO REMOVE,? AND A POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE "ADHESIVE IS TOO STRONG." THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: "WASH PENIS WITH MILD SOAP AND WARM WATER. DRY THOROUGHLY. TRIM PUBIC HAIR IF NECESSARY. OPEN PACKAGE AT PERFORATION. TO REMOVE PLASTIC INSERT, SQUEEZE CATHETER AT THE TOP OF THE WHITE CONE AND PULL TO RELEASE. UNROLL SELF-ADHERING CATHETER OVER PENIS. GENTLY SQUEEZE THE CATHETER TO PROPERLY SEAL ADHESIVE TO THE SKIN. CONNECT TO COLLECTION BAG. IMPORTANT: WEAR TIME MAY BE SIGNIFICANTLY REDUCED IF ADHESIVE IS NOT PROPERLY SEALED TO THE SKIN."

D

Patient 1

IT WAS REPORTED THAT THE ADHESIVE WAS TOO STRONG, WHICH CAUSED THE PATIENT TO SPEND 30 MINUTES TRYING TO SOAK IT OFF IN THE SHOWER. NO MEDICAL INTERVENTION WAS REQUIRED.