RIVERLON
Report
- Report Number
- 3006981798-2023-00008
- Event Type
- Malfunction
- Date Received
- March 21, 2023
- Report Date
- March 15, 2023
- Manufacturer
- RIVERPOINT MEDICAL LLC
- Product Code
- NBY
- PMA / PMN Number
- K100006
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
THIS INFORMATION IS BASED ENTIRELY ON A GLOBAL ANONYMOUS SURVEY OF 30 PHYSICIANS ON THEIR EXPERIENCE OF THE RIVERLON® (NYLON). PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. PLEASE NOTE, MULTIPLE PATIENTS AND PRODUCTS WITH MANY DIFFERENT SERIAL NUMBERS AND LOT NUMBERS WERE REFERENCED WITHIN A PRODUCT FAMILY IN THE SURVEY; THEREFORE, A ONE-TO-ONE CORRELATION COULD NOT BE MADE WITH UNIQUE PRODUCT SERIAL/LOT NUMBERS. THE MODEL LISTED IN THE REPORT IS REPRESENTATIVE OF THE MODEL FAMILY, AS THERE IS NO SPECIFIC MODEL LISTED. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED.
ACCORDING TO THE SURVEY, 22 USERS REPORTED A SUTURE BREAK, TRANSITORY LOCAL IRRITATION AND, IRRITATION WHEN SKIN SUTURES ARE LEFT IN PLACE FOR GREATER THAN SEVEN DAYS; 18 USERS REPORTED NEEDLE BREAK; 19 USERS REPORTED A NEEDLE DETACHMENT; 20 USERS REPORTED REACTION; 25 USERS REPORTED WOUND DEHISCENCE OR DELAYED WOUND HEALING AND MINIMAL ACUTE INFLAMMATORY REACTION; 24 USERS REPORTED INFECTION AND, 11 USERS REPORTED CALCULI FORMATION. SURVEY RESPONDENTS WERE GIVEN THE OPTION TO WRITE IN ADDITIONAL ADVERSE EVENTS ENCOUNTERED THAT WERE NOT LISTED ON THE SURVEY. ALL 30 RESPONDENTS HAD POSITIVE FEEDBACK AND 1 PHYSICIAN WROTE "HYPERSTRETCH FILAMENT".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 9234 | RIVERLON | NON-ABSORBABLE SUTURE | NBY | RIVERPOINT MEDICAL LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |