NURSE ASSIST, LLC
Report
- Report Number
- 3002695476-2024-00019
- Event Type
- Injury
- Date Received
- April 22, 2024
- Date of Event
- September 11, 2023
- Report Date
- April 12, 2024
- Manufacturer
- NURSE ASSIST, LLC
- Product Code
- FRO
- UDI-DI
- 00850421008822
- PMA / PMN Number
- K083042
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
THIS MDR IS IN RESPONSE TO THE LETTER RECEIVED ON (B)(6) 2024 BY NURSE ASSIST FROM AMAZON'S LAW FIRM DUE TO THE LITIGATIONS OF (B)(4). NURSE ASSIST DID NOT RECEIVE ANY COMPLAINT NOTICE DIRECTLY FROM (B)(6) ABOUT THE COMPLICATIONS HE HAD WITH NURSE ASSIST PRODUCT. ON (B)(6) 2024, NURSE ASSIST OPENED THIS EVENT AS A COMPLAINT AND WILL CONDUCT AN INVESTIGATION WITH INFORMATION THAT WAS PROVIDED IN THE LETTER.
THIS MDR IS IN RESPONSE TO THE LETTER RECEIVED ON 02-FEB-2024 BY NURSE ASSIST FROM AMAZON'S LAW FIRM DUE TO THE LITIGATIONS OF (B)(6). NURSE ASSIST DID NOT RECEIVE ANY COMPLAINT NOTICE DIRECTLY FROM (B)(6) ABOUT THE COMPLICATIONS HE HAD WITH NURSE ASSIST PRODUCT. ON (B)(6) 2024, NURSE ASSIST OPENED THIS EVENT AS A COMPLAINT AND WILL CONDUCT AN INVESTIGATION WITH INFORMATION THAT WAS PROVIDED IN THE LETTER. ON (B)(6) 2024 NURSE ASSIST REOPENED THE INVESTIGATION FOR THIS EVENT AFTER BEING PROVIDED WITH THE PART AND LOT NUMBER OF THE PRODUCT USED.
ON (B)(6) 2024, NURSE ASSIST RECEIVED A LETTER FROM (B)(4) VIA E-MAIL. DESCRIPTION OF E-MAIL:CLAIMANT ALLEGES HE SUFFERED SEVERE INJURY, INCLUDING TOE AMPUTATIONS, DUE TO HIS USE OF NONSTERILE SALINE SOLUTION PURCHASED FROM A THIRD-PARTY SELLER, (B)(4), THROUGH AMAZON.COM. SPECIFICALLY, CLAIMANT CLAIMS THAT HE PURCHASED 0.9% SODIUM CHLORIDE STERILE SALINE 250ML MANUFACTURED BY NURSE ASSIST. HE ALLEGES HE USED THE PRODUCT STARTING IN (B)(6) 2023, UNTIL (B)(6) 2023, WHEN HE NOTICED TOE DISCOLORATION ON HIS LEFT FOOT. HE WAS LATER DIAGNOSED WITH GANGRENE AND UNDERWENT AMPUTATION OF HIS LEFT 2ND AND 3RD TOES. CLAIMANT ALLEGES THE SALINE SOLUTION WAS PART OF A RECALL CAMPAIGN AS A RESULT OF BEING NONSTERILE.
ON (B)(6) 2024, NURSE ASSIST RECEIVED A LETTER FROM (B)(6) VIA E-MAIL. DESCRIPTION OF E-MAIL: CLAIMANT ALLEGES HE SUFFERED SEVERE INJURY, INCLUDING TOE AMPUTATIONS, DUE TO HIS USE OF NONSTERILE SALINE SOLUTION PURCHASED FROM A THIRD-PARTY SELLER, (B)(4), THROUGH AMAZON.COM. SPECIFICALLY, CLAIMANT CLAIMS THAT HE PURCHASED 0.9% SODIUM CHLORIDE STERILE SALINE 250ML MANUFACTURED BY NURSE ASSIST. HE ALLEGES HE USED THE PRODUCT STARTING IN (B)(6) 2023, UNTIL (B)(6) 2023, WHEN HE NOTICED TOE DISCOLORATION ON HIS LEFT FOOT. HE WAS LATER DIAGNOSED WITH GANGRENE AND UNDERWENT AMPUTATION OF HIS LEFT 2ND AND 3RD TOES. CLAIMANT ALLEGES THE SALINE SOLUTION WAS PART OF A RECALL CAMPAIGN AS A RESULT OF BEING NONSTERILE. ON 22-JUL-2024 ADDITIONAL INFORMATION WAS PROVIDED VIA EMAIL INCLUDING A PHOTO OF THE PRODUCT USED. THE PHOTO SHOWED ITEM PART NUMBER 6270, LOT # 23055547.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2241672 | NURSE ASSIST, LLC | 0.9% NORMAL SALINE FOR IRRIGATION USP IN SCREW BOTTLE TOP | FRO | NURSE ASSIST, LLC | 6270 | 23055547 | 00850421008822 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Life Threatening| H| S |