MAUDE MDR 4450382

MDR report key
4450382
Report number
MW5040334
Event key
0
Event type
3
Date of event
2015-01-18
Date received
2015-01-19
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PLASTIBELL HOSP. BULK 1.1CMPLASTIBELLBRIGGS HEALTHCAREFHGD 9211D 92114J06 N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-01-1901. R

Event Narratives#

D

Patient 1

WHILE DOING A ROUTINE PLASTIBELL CIRC BY DOCTOR SHE PLACED AN INTACT PLASTIBELL RING ON THE PENIS AND TIED THE STRING PER PROTOCOL AND TOOK FORESKIN OFF. ONCE TOPE OF PLASTIBELL WAS TAKEN OFF IT WAS NOTICED BY NURSE AND DOCTOR THAT THE PLASTIBELL WAS CRACKED IN TWO SPOTS AND FOLDING IN ON THE PENIS. THE BLEEDING WAS MINIMAL AT THIS POINT AND DOCTOR CALLED UROLOGY DOCTOR RIGHT AFTER PLASTIBELL WAS NOTICED TO BE (B)(6) FOR FURTHER EVAL. FROM PROCEDURE NOTE: AT THE TIME OF PLACEMENT OF THE PLASTIBELL, THE 1.1 PLASTIBELL USED IN THIS PROCEDURE WAS COMPLETELY INTACT. THE PLASTIBELL WAS PLACED OVER THE GLANS AND THE FORESKIN WAS PULLED BACK OVER THE GLANS AND PLASTIBELL, IN CORRECT POSITION TO TIE THE STRING. THE STRING WAS THEN TIED. AS THE STRING WAS TIED, THE PLASTIBELL REMAINED A COMPLETELY INTACT CIRCLE, THE SKIN BLANCHED AS EXPECTED. THE REMAINING FORESKIN WAS REMOVED WITH STERILE SCISSORS AND THEN THE TAB WAS REMOVED FROM THE PLASTIBELL. THERE DID NOT SEEM TO BE ANYTHING OUT OF THE ORDINARY WHEN REMOVING THE TAB, NORMAL AMOUNT OF PRESSURE REQUIRED TO REMOVE. AFTER REMOVING THE TAB, IT WAS NOTED THAT THE PLASTIBELL HAD CRACKED AT TWO POINTS AND WAS NO LONGER IN THE SHAPE OF CIRCLE SURROUNDING THE GLANS. THE TWO EDGE OF THE CRACKED PLASTIBELL SHIFTED SO THAT BROKEN EDGES OF THE RING WERE OVERLAPPING EACH OTHER. DUE TO CONCERN OF THE CRACKED PLASTIBELL, INABILITY TO ACHIEVE COMPLETE HEMOSTASIS DUE TO THE CRACKED PLASTIBELL NOT ALLOWING THE STRING TO BE TIGHT, AND CONCERN THAT THE PLASTIBELL COULD SHIFT AND CAUSE PRESSURE ON THE GLANS, UROLOGY WAS CONSULTED.

D

Patient 1

ADDITIONAL INFORMATION RECEIVED FROM REPORTER 06/29/2015: INITIAL REPORT STATED THAT AN INTACT PLASTIBELL RING WAS PLACED ON THE PATIENT'S PENIS AND TIES PER PROTOCOL. THE FORESKIN WAS REMOVED. UPON REMOVAL OF THE HANDLE, THE NURSE AND DOCTOR NOTICED THAT THE PLASTIBELL WAS CRACKED IN TWO SPOTS AND FOLDING IN ON THE PENIS. THE PLASTIBELL WAS NO LONGER IN THE SHAPE OF A CIRCLE. THE TWO EDGES OF THE CRACKED UNIT SHIFTED SO THAT THE BROKEN EDGES WERE OVERLAPPING.