FDA.reportPublic FDA data

MAUDE MDR 308271

MDR report key
308271
Report number
MW4002900
Event key
0
Event type
3
Date of event
2000-11-21
Date received
2000-11-24
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
0
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PLASTIBELL 1-2 CMCIRCUMCISION BELLHOLLISTER INC.FHGNANI7F11ALNY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12000-11-240

Event Narratives#

D

Patient 1

HAVE HAD SEVERAL STRINGS ON THE PRODUCT THAT HAVE BROKEN WHILE PERFORMING CIRCUMCISION. THE STRING BREAKS WHEN BEING TIGHTENED BEFORE KNOTTING IT AND REMOVING FORESKIN. HAVE BEEN TOLD REPEATEDLY BY THE CO THAT THEY HAVE NEVER RECEIVED A PRODUCT COMPLAINT OF THIS NATURE AND HAVE NO OTHER CENTERS REPORTING THIS PROBLEM.

D

Patient 1

ADD'L INFO REC'D FROM MFR 3/14/01: HOLLISTER INC HAD REQUESTED AND DID NOT RECEIVE SAMPLES OF DEVICE FROM THE USER FACILITY; THEREFORE, TESTING OF THE ACTUAL DEVICE COULD NOT BE PERFORMED. DURING THE INVESTIGATION, THE FACILITY REPORTED THAT THE BREAKAGE OF THE LIGATURE WAS OCCURRING WHEN USED BY ONE PHYSICIAN. THE FACILITY ALSO REPORTED THAT OTHER PHYSICIANS IN THE FACILITY HAVE USED THE DEVICE WITHOUT INCIDENT. HOLLISTER INC HAS REVIEWED ITS PRODUCT COMPLAINT FILES AND HAS DETERMINED THAT NO ADVERSE TRENDS EXIST FOR THIS PRODUCT.