FDA.reportPublic FDA data

MAUDE MDR 4433742

MDR report key
4433742
Report number
9612501-2015-00029
Event key
0
Event type
3
Date of event
2014-12-19
Date received
2015-01-20
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
SHARON MURPHY
Address
60 MIDDLETOWN AVE NORTH HAVEN CT 06473 US
Phone
203-203-2034
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1BLTPRT PLUS 12MM OBTR + 5MM-12MM SEAL RTDISPOSABLE SURGICAL ACCESS DEVICECOVIDIENGDH179775P179775PJ4D1539XY R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-01-200

Event Narratives#

D

Patient 1

PROCEDURE: GYNECOLOGY. ACCORDING TO THE REPORTER: UPON MANIPULATION OF THE BLUNT GRIP, THE INNER PART OF THE OBTULATOR HAPPENED TO BE BROKEN. A NEW ONE WAS OPENED AND THEN THE SAME EVENT OCCURRED CONSECUTIVELY. OPERATING TIME NOT EXTENDED. NEW ONE WAS OPENED TO COMPLETE THE CASE WITH NO PROBLEM. NO PATIENT HARM.

N

Patient 1

(B)(4)

N

Patient 1

(B)(4).