MAUDE MDR 5980070

MDR report key
5980070
Report number
MW5065049
Event key
0
Event type
3
Date of event
2016-09-21
Date received
2016-09-23
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
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
1VAGINAL SPECULUMVAGINAL SPECULUMUNKHDF* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-09-2301. O

Event Narratives#

D

Patient 1

ON (B)(6) 2016, I VISITED THE (B)(6) WOMAN'S CENTER IN (B)(6). DURING THE EXAMINATION, I NOTICED THAT THE OBGYN CLAMP WAS NOT ON THE TABLE. EVERY OTHER ITEM WAS ON THE TABLE. THE GEL THAT THEY USE AND OTHER MEDICAL DEVICES AS NEEDED. DURING THE EXAM, THE DOCTOR ASKED FOR THE OBGYN CLAMP. I DO NOT RECALL THE ASSISTANT PLACING THE CLAMP ON THE TABLE. SHE WENT IN THE CABINET AND GOT A CLAMP WHICH WAS LOCATED IN A BLACK DISH PAN. THERE WAS ONLY ONE CLAMP AND WHEN SHE FINISHED USING IT, SHE PUT THE CLAMP BACK IN THE DISHPAN. WHEN EVERYONE EXITED THE OFFICE. I OPENED THE CABINET TO FIND THE CLAMP IN THE PAN AS I THOUGHT SHE PLACED IT, BUT THE MOST SCARY PART AND CONCERNING PART IS THAT THE DISHPAN ODOR SMELLED HORRIBLE. IT SMELLED LIKE IT HAD NEVER BEEN CLEANED EVER AND IT SMELLED VERY STRONG OF FEMININE HYGIENE. IT WAS OBVIOUS THE PAN WAS NEVER EVER CLEANED. IF THEY ARE INTACT CLEANING THE OBGYN EXAMINATION CLAMPS THEN WHY IS THE SMELL OF THE PAN THAT THEY ARE STORING THE USED/ OR PERHAPS UNUSED CLAMPS IN SMELLING SO PUTRID. I DON'T HAVE THE ACTUAL PRODUCT BUT I DO HAVE PICTURES OF IT. IT WAS AN OBGYN EXAM AND I THINK THEY ARE USING THE SAME METAL CLAMP ON THE FEMALES AND NOT SANITIZING AND THE STORAGE LOCATION FOR THE CLAMP SMELLS EXTREMELY STRONG OF FEMININE HYGIENE AND IT SMELLS EXTREMELY UNCLEAN. IT IS BEING STORED UNDER THE SINK IN THE OBGYN OFFICE. PLEASE KNOW THAT I DO HAVE PICTURES OF THE CLAMP IN THE BLACK DISHPAN THAT WAS LOCATED UNDER THE SINK. MY CONCERN IS THEY INSERTED THIS CLAMP INSIDE OF ME AND I'M NOT SURE IF IT WAS SANITIZED. ALSO, THERE WERE MANY PREGNANT WOMEN, CHILDREN AND FAMILIES THERE WAITING FOR SERVICE.