FDA.reportPublic FDA data

MAUDE MDR 1700780

MDR report key
1700780
Report number
8021764-2010-00002
Event key
0
Event type
3
Date of event
2010-01-01
Date received
2010-05-26
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
PATTY CRONAN
Address
1755 A WEST OAK COMMONS CT MARIETTA GA 30062 US
Phone
770-770-7709
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1UNIFINE PENTIPSUNIFINEOWEN MUMFORD, LTD.FMIAN35300905753R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12010-05-2601. O

Event Narratives#

D

Patient 1

OWEN MUMFORD INC WAS CONTACTED ON (B) (6) 2010 BY A MOTHER WHOM HAD INJECTED HER DAUGHTER WITH HER GROWTH HORMONE INJECTION AND WHEN SHE REMOVED THE NEEDLE FROM HER DAUGHTER'S SKIN, SHE STATED THAT THE NEEDLE HAD BROKEN OFF IN HER DAUGHTER'S ARM. SHE TOOK HER DAUGHTER TO A PLASTIC SURGEON WHO OPTED NOT TO PERFORM SURGERY, 'AS THE DAUGHTER HAS A BLEEDING DISORDER AND THE NEEDLE IS SO SMALL THAT THE CHANCES OF FINDING THE NEEDLE ARE SMALL'.

N

Patient 1

(B) (6) 2010 - OWEN MUMFORD FORWARDED A MEDICAL QUESTIONNAIRE AND A REPLACEMENT BOX OF PENTIPS TO THE PATIENT'S MOTHER. ON 1ST FEBRUARY 2010 - PATIENT'S MOTHER RETURNED COMPLETED MEDICAL QUESTIONNAIRE. OM TELEPHONED THE PATIENT REGARDING THE RETURN OF THE NEEDLE HUB FOR INVESTIGATION AND IT WAS AGREED THE NEEDLE HUB WOULD BE RETURNED. ON 16TH APRIL 2010 - PATIENT'S MOTHER WAS AGAIN CONTACTED AS NO NEEDLE HUB HAD BEEN RETURNED AND PATIENT'S MOTHER STATED THAT HER AND HER HUSBAND HAD DECIDED NOT TO SEND THE HUB BACK. ON 29TH APRIL 2010 - LETTER FORWARDED TO PATIENT'S MOTHER EXPLAINING THAT OM COULD NOT COMPLETE A THOROUGH INVESTIGATION IF THE NEEDLE HUB COULD NOT BE RETURNED TO THE MANUFACTURERS. OM ALSO ASSURED PATIENT'S MOTHER THAT A COPY OF ALL FINDINGS WOULD BE FORWARDED ON COMPLETION OF THE NEEDLE HUB INVESTIGATION. AT THE DATE OF THIS REPORT, THE NEEDLE HUB HAS STILL NOT BEEN RETURNED TO OM.