MAUDE Adverse Event Report: SPECULUM; SPECULUM, VAGINAL, METAL

SPECULUM; SPECULUM, VAGINAL, METAL

Device Problem Use of Device Problem (1670)

Patient Problem Laceration(s) (1946)

Event Date 06/07/2023

Event Type Injury

Event Description

During pap smear under anesthesia in the operating room, the patient received a small laceration on the patient's hymn when inserting the speculum.

1 Device was Involved in the Event
Brand Name	SPECULUM
Type of Device	SPECULUM, VAGINAL, METAL
MDR Report Key	17136289
MDR Text Key	317316828
Report Number	MW5118416
Device Sequence Number	1
Product Code	HDF
Combination Product (y/n)	N
Reporter Country Code	US
Number of Events Reported	1
Summary Report (Y/N)	N
Report Source	Voluntary
Reporter Occupation	Nurse
Type of Report	Initial
Report Date	06/12/2023
1 Patient was Involved in the Event
Is this an Adverse Event Report?	No
Is this a Product Problem Report?	Yes
Device Operator	Health Professional
Was Device Available for Evaluation?	Yes
Is the Reporter a Health Professional?	Yes
Initial Date Manufacturer Received	Not provided
Initial Date FDA Received	06/14/2023
Is This a Reprocessed and Reused Single-Use Device?	No
Patient Sequence Number	1
Patient Outcome(s)	Required Intervention;
Patient Age	37 YR
Patient Sex	Female