NURSE ASSIST, LLC
Report
- Report Number
- 3002695476-2024-00024
- Event Type
- Death
- Date Received
- June 13, 2024
- Date of Event
- October 14, 2022
- Report Date
- May 1, 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
FOLLOWED-UP WITH CUSTOMER TO OBTAIN MORE INFORMATION ABOUT THE PRODUCT THAT WAS USED ON THE HUSBAND.
FOLLOWED-UP WITH CUSTOMER TO OBTAIN MORE INFORMATION ABOUT THE PRODUCT THAT WAS USED ON THE HUSBAND.
FOLLOWED-UP WITH CUSTOMER TO OBTAIN MORE INFORMATION ABOUT THE PRODUCT THAT WAS USED ON THE HUSBAND.
ON (B)(6) 2024, NURSE ASSIST RECEIVED A COMPLAINT VIA E-MAIL FROM (B)(6). DESCRIPTION OF E-MAIL: ON SATURDAY, (B)(6) 2024 AT 10:24:59 AM CST, (B)(6) WROTE: HELLO, I AM WRITING ON BEHALF OF MY HUSBAND, (B)(6). HE PASSED AWAY (B)(6) 2023, AT THE TIME HE DID HAVE BLOOD INFECTION, MERSA. WOULD THIS RECALL HAVE CAUSED THIS BLOOD INFECTION? ON THURSDAY, (B)(6) 2024 AT 06:52:52 PM CST, (B)(6) WROTE: HELLO , I WOULD LIKE TO FOLLOW UP ON MY INQUIRY IN (B)(6). I RECEIVED A RECALL NOTIFICATION , CAN YOU TELL ME WHAT TIMEFRAME THAT MY HUSBAND , (B)(6) WOULD HAVE RECEIVED THE SALINE SOLUTION? PAST 14 MONTHS, BEFORE HE PASSED , HE HAD CONTINUOUS BLOOD INFECTIONS , WHICH CAUSED HIM MANY TRIPS TO THE ICU I WOULD REALLY LIKE TO GET SOME DETAILS ON THIS RECALL. I HAVE ALSO BE REACHED OUT TO THE FDA.
ON (B)(6) 2024, NURSE ASSIST RECEIVED A COMPLAINT VIA E-MAIL FROM (B)(6). DESCRIPTION OF E-MAIL: ON SATURDAY, ON (B)(6), 2024 AT 10:24:59 AM CST, (B)(6) WROTE: HELLO, I AM WRITING ON BEHALF OF MY HUSBAND, (B)(6) . HE PASSED AWAY (B)(6) , 2023, AT THE TIME HE DID HAVE BLOOD INFECTION, MERSA WOULD THIS RECALL HAVE CAUSED THIS BLOOD INFECTION? ON THURSDAY, ON (B)(6) 2024 AT 06:52:52 PM CST, (B)(6) WROTE: HELLO, I WOULD LIKE TO FOLLOW UP ON MY INQUIRY IN (B)(6) I RECEIVED A RECALL NOTIFICATION, CAN YOU TELL ME WHAT TIMEFRAME THAT MY HUSBAND, (B)(6) WOULD HAVE RECEIVED THE SALINE SOLUTION? PAST 14 MONTHS, BEFORE HE PASSED, HE HAD CONTINUOUS BLOOD INFECTIONS, WHICH CAUSED HIM MANY TRIPS TO THE ICU I WOULD REALLY LIKE TO GET SOME DETAILS ON THIS RECALL. I HAVE ALSO BE REACHED OUT TO THE FDA.
ON 20-JAN-24, NURSE ASSIST RECEIVED A COMPLAINT VIA E-MAIL FROM (B)(6). DESCRIPTION OF E-MAIL: ON SATURDAY, JANUARY 20, 2024, AT 10:24:59 AM CST, (B)(6) WROTE: HELLO, I AM WRITING ON BEHALF OF MY HUSBAND, (B)(6). HE PASSED AWAY (B)(6) 2023, AT THE TIME HE DID HAVE BLOOD INFECTION, MERSA. WOULD THIS RECALL HAVE CAUSED THIS BLOOD INFECTION? ON THURSDAY, MARCH 7, 2024, AT 06:52:52 PM CST, (B)(6) WROTE: HELLO, I WOULD LIKE TO FOLLOW UP ON MY INQUIRY IN JANUARY. I RECEIVED A RECALL NOTIFICATION, CAN YOU TELL ME WHAT TIMEFRAME THAT MY HUSBAND, (B)(6) WOULD HAVE RECEIVED THE SALINE SOLUTION? PAST 14 MONTHS, BEFORE HE PASSED, HE HAD CONTINUOUS BLOOD INFECTIONS, WHICH CAUSED HIM MANY TRIPS TO THE ICU I WOULD REALLY LIKE TO GET SOME DETAILS ON THIS RECALL. I HAVE ALSO BE REACHED OUT TO THE FDA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1123730 | NURSE ASSIST, LLC | 0.9% NORMAL SALINE FOR IRRIGATION USP IN SCREW BOTTLE TOP | FRO | NURSE ASSIST, LLC | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Death |