FDA Adverse Event
Injury
Summary report: N
GRIP-LOK MEDIUM STERILE MCK
MDR report key: 23250972
·
Received October 8, 2025
Report
- Report Number
- 2182318-2025-00088
- Event Type
- Injury
- Date Received
- October 8, 2025
- Report Date
- September 15, 2025
- Manufacturer
- TIDI PRODUCTS LLC
- Product Code
- KMK
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
H3: PRODUCT HAS NOT BEEN RECEIVED BY THE MANUFACTURER. THEREFORE, THIS EVENT IS REPORTED BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER. CONFIRMATION OF THE CUSTOMER'S COMPLAINT AND THE ROOT CAUSE COULD NOT BE DETERMINED. NO LOT/SERIAL NUMBER PROVIDED THEREFORE NO DEVICE HISTORY REVIEW CAN BE PERFORMED. THE CUSTOMER WAS CONTACTED TO REQUEST PRODUCT RETURN AND/OR IMAGES TO SUPPORT THE EVALUATION; HOWEVER, NO RESPONSE HAS BEEN RECEIVED TO DATE. THE INSTRUCTIONS FOR USE ARE ADEQUATE IN PROVIDING CLEAR AND CONCISE WARNINGS. AT THIS TIME, THERE IS NO EVIDENCE THAT A MANUFACTURING ERROR CONTRIBUTED TO THE REPORTED FAILURE.
Description of Event or Problem · 0
REPORTED TO THE MANUFACTURER BY A DISTRIBUTOR. IT WAS REPORTED THAT 3 PATIENTS HAD BLISTERING AFTER USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2583495 | GRIP-LOK MEDIUM STERILE MCK | DEVICE, INTRAVASCULAR CATHETER SECUREMENT | KMK | TIDI PRODUCTS LLC | 18-3300M | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |