FDA.reportPublic FDA data

MAUDE MDR 1474821

MDR report key
1474821
Report number
3006365741-2009-00001
Event key
0
Event type
3
Date of event
2009-05-11
Date received
2009-06-22
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#

Address
3150 STATE POST RD SUITE 103 MEMPHIS TN 38133 US
Phone
901-901-9013
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1GYN DISPOSABLE TENACULUM 356TTENACULUMGYN-DISPOSABLESHDC356T935K 60134034R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12009-06-2201. O

Event Narratives#

D

Patient 1

NURSE PRACTITIONER SAYS THAT ONE OF THE TENACULUM TIPS BROKE WHILE SHE WAS REMOVING THE TENACULUM FROM THE CERVIX (AFTER AN IUD INSERTION PROCEDURE). SHE TRIED TO FIND THE BROKEN PIECE AND WAS UNSUCCESSFUL. THERE WAS NO FURTHER INTERVENTION REQUIRED. THE TIP PROTECTOR WAS IN PLACE WHEN PACKAGE WAS OPENED. THE NURSE PRACTITIONER DISPOSED OF THE TENACULUM SO IT CANNOT BE RETURNED FOR EVAL. NURSE PRACTITIONER DID NOT NOTIFY MFR AT THE TIME OF THE OCCURRENCE AS SHE DID NOT FEEL THAT THIS OCCURRENCE WAS A BIG CONCERN. THE INCIDENT WAS DISCOVERED ON (B)(6) 2009 WHEN MFR MADE A SALES FOLLOW-UP TELEPHONE CALL. ON 06/22/2009, MFR MADE A FOLLOW-UP TELEPHONE CALL TO THE NURSE PRACTITIONER WHO SAID THAT THERE WERE NO COMPLICATIONS WITH THE PT.