NURSE ASSIST, LLC
Report
- Report Number
- 3002695476-2024-00042
- Event Type
- Death
- Date Received
- July 25, 2024
- Report Date
- June 24, 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
A FOLLOW-UP CALL WAS SENT TO (B)(6) BY THE COMPLAINTS DEPARTMENT ON 6/24/2024 REQUESTING ADDITIONAL INFORMATION TO AID WITH REPORTING AND WITH THE INVESTIGATION.
UPDATED INFORMATION PER PHONE CALL ON (B)(6) 2024: PATIENT WAS UNSURE IF NURSE ASSIST PRODUCT WAS USED.
FOLLOW-UP 01: UPDATED INFORMATION PER PHONE CALL ON (B)(6) 2024: PATIENT WAS UNSURE IF NURSE ASSIST PRODUCT WAS USED. FOLLOW-UP 02: A CORRECTION WAS MADE IN SECTION H11 WHERE 5-DAY BOX WAS INCORRECTLY CHECKED WHEN IT SHOULD HAVE BEEN 30-DAY.
ON 06/21/2024, CUSTOMER SERVICE RECEIVED A CALL FROM (B)(6). CUSTOMER SERVICE DEPARTMENT SENT AN EMAIL DESCRIBING THE CALL THEY HAD WITH (B)(6) TO THE COMPLAINTS DEPARTMENT ON 06/21/2024. DESCRIPTION OF EMAIL SENT TO COMPLAINTS DEPARTMENT: SHE WAS CHANGING THE DRESSINGS ON HER HUSBAND WOUNDS, AND HE SUDDENLY HAD A RAPID DECLINE. THERE WAS SOME YELLOW DRAINAGE FROM THE TUBE THAT THE NURSE NOTICED. SHE JUST WANTS PIECE OF MIND THAT IT WAS NO ONE'S FAULT JUST LIFE. HER NAME IS (B)(6) AND HER HUSBAND'S NAME WAS (B)(6).
UPDATED INFORMATION: NURSE ASSIST CONTACTED PATIENT ON (B)(6) 2024 TO OBTAIN ADDITIONAL INFORMATION. PATIENT DID NOT HAVE PART NUMBER OR LOT NUMBER AND WAS UNSURE IF THE PRODUCT USED WAS FROM NURSE ASSIST. ORIGINAL INFORMATION: ON 06/21/2024, CUSTOMER SERVICE RECEIVED A CALL FROM (B)(6). CUSTOMER SERVICE DEPARTMENT SENT AN EMAIL DESCRIBING THE CALL THEY HAD WITH (B)(6) TO THE COMPLAINTS DEPARTMENT ON 06/21/2024. DESCRIPTION OF EMAIL SENT TO COMPLAINTS DEPARTMENT: SHE WAS CHANGING THE DRESSINGS ON HER HUSBAND WOUNDS, AND HE SUDDENLY HAD A RAPID DECLINE. THERE WAS SOME YELLOW DRAINAGE FROM THE TUBE THAT THE NURSE NOTICED. SHE JUST WANTS PIECE OF MIND THAT IT WAS NO ONE'S FAULT JUST LIFE. HER NAME IS (B)(6) AND HER HUSBAND'S NAME WAS (B)(6).
UPDATED INFORMATION: NURSE ASSIST CONTACTED PATIENT ON (B)(6) 2024 TO OBTAIN ADDITIONAL INFORMATION. PATIENT DID NOT HAVE PART NUMBER OR LOT NUMBER AND WAS UNSURE IF THE PRODUCT USED WAS FROM NURSE ASSIST. ORIGINAL INFORMATION: ON 06/21/2024, CUSTOMER SERVICE RECEIVED A CALL FROM (B)(6). CUSTOMER SERVICE DEPARTMENT SENT AN EMAIL DESCRIBING THE CALL THEY HAD WITH (B)(6) TO THE COMPLAINTS DEPARTMENT ON 06/21/2024. DESCRIPTION OF EMAIL SENT TO COMPLAINTS DEPARTMENT: SHE WAS CHANGING THE DRESSINGS ON HER HUSBAND WOUNDS, AND HE SUDDENLY HAD A RAPID DECLINE. THERE WAS SOME YELLOW DRAINAGE FROM THE TUBE THAT THE NURSE NOTICED. SHE JUST WANTS PIECE OF MIND THAT IT WAS NO ONE'S FAULT JUST LIFE. HER NAME IS (B)(6) AND HER HUSBAND'S NAME WAS (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 365348 | NURSE ASSIST, LLC | DRESSING, WOUND, DRUG | FRO | NURSE ASSIST, LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Death |