NURSE ASSIST, LLC
Report
- Report Number
- 3002695476-2024-00027
- Event Type
- Injury
- Date Received
- June 13, 2024
- Date of Event
- January 11, 2024
- Report Date
- June 11, 2024
- Manufacturer
- NURSE ASSIST, LLC
- Product Code
- FRO
- PMA / PMN Number
- K083042
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
AN EMAIL WAS SENT TO THE PRODUCT REMOVAL INFO EMAIL ADDRESS BY (B)(6) ON 1/11/2024. THE EMAIL WAS FORWARDED TO THE COMPLAINT DEPARTMENT ON 5/20/2024, WHICH INITIATED NURSE ASSIST'S INVESTIGATION OF THE REPORTED INCIDENT AND DETERMINATION THAT THE NOTED INCIDENT WAS REPORTABLE. A FOLLOW-UP EMAIL WAS SENT TO (B)(6) BY THE COMPLAINT DEPARTMENT ON 5/20/2024 REQUESTING ADDITIONAL INFORMATION TO AID WITH REPORTING AND WITH THE INVESTIGATION. THE PRODUCT REMOVAL INFO EMAIL ADDRESS WAS INTENDED TO BE USED SOLELY FOR FACILITATING RETURN AND REPLACEMENT OF PRODUCT AND WAS NOT BEING REVIEWED FOR COMPLAINT INFORMATION, WHICH RESULTED IN THE DELAY OF REPORTING THIS INCIDENT. THE PRODUCT REMOVAL INFO EMAIL INBOX IS BEING EXPEDITIOUSLY REVIEWED TO IDENTIFY ANY OTHER INCIDENT RELATED INFORMATION THAT WOULD BE CONSIDERED AS A COMPLAINT. CUSTOMER RESPONDED BACK ON 6/11/2024 STATING: NO, I DON'T HAVE PHOTOS I CAN PULL UP MY AMAZON ORDER THE PRODUCT WAS USED TO WASH INSIDE INTIMATE AREAS.
COMMENTS INCLUDED IN EMAIL RECEIVED FROM COMPLAINANT: HELLO I RECENTLY USED THIS PRODUCT AND HAVE BEEN EXPERIENCING ISSUES WITH MY HEART. PLEASE GET BACK TO ME IMMEDIATELY (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 784224 | NURSE ASSIST, LLC | STERILE WATER FOR IRRIGATION USP IN SCREW BOTTLE TOP | FRO | NURSE ASSIST, LLC | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |