FDA Adverse Event
Injury
Summary report: N
NURSE ASSIST, LLC
MDR report key: 18475009
·
Received January 9, 2024
Report
- Report Number
- 3002695476-2023-00042
- Event Type
- Injury
- Date Received
- January 9, 2024
- Date of Event
- May 23, 2023
- Report Date
- December 29, 2023
- Manufacturer
- NURSE ASSIST, LLC
- Product Code
- FRO
- UDI-DI
- 00850421008846
- PMA / PMN Number
- K083042
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
MEDWATCH REPORT MW5149040.
Description of Event or Problem · 0
ON 13-DEC-23, NURSE ASSIST RECEIVED A MEDWATCH REPORT VIA E-MAIL OF THE FOLLOWING EVENT DESCRIPTION FROM MEDWATCH REPORT: I USED THE NURSE ASSIST LLC STERILE SALINE PRODUCT TO IRRIGATE A SEROMA IN MY ABDOMEN FROM (B)(6) OF 2023. I HAVE SINCE HAD 3 DÉBRIDEMENT SURGERIES TO CLEAR DAMAGED TISSUE FROM MY WOUND. I HAD TWO AS AN OUT PATIENT AND THE MOST RECENT INPATIENT. THEY ONLY DID A CULTURE ON THE MOST RECENT AND IT GREW OUT MRSA (METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS). I HAVE BEEN PROGRESSIVELY SICKER SINCE MAY. SIGNIFICANT PHYSICAL DETERIORATION SINCE (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 589940 | NURSE ASSIST, LLC | 0.9% NORMAL SALINE FOR IRRIGATION USP IN SCREW BOTTLE TOP | FRO | NURSE ASSIST, LLC | 6281 | 23034968 | 00850421008846 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention| H| S| L |