VAGINAL SPECULUM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-23 for VAGINAL SPECULUM manufactured by Unk.

Event Text Entries

[55889056] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5065049
MDR Report Key5980070
Date Received2016-09-23
Date of Report2016-09-23
Date of Event2016-09-21
Date Added to Maude2016-09-27
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameVAGINAL SPECULUM
Generic NameVAGINAL SPECULUM
Product CodeHDF
Date Received2016-09-23
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerUNK
Manufacturer AddressUNK UNK


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2016-09-23

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.