FDA Adverse Event
Injury
Summary report: N
GRIP-LOK
MDR report key: 7906551
·
Received September 25, 2018
Report
- Report Number
- 2182318-2018-00007
- Event Type
- Injury
- Date Received
- September 25, 2018
- Date of Event
- March 2, 2016
- Report Date
- September 9, 2018
- Manufacturer
- TIDI PRODUCTS, LLC
- Product Code
- KMK
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS BEING SUBMITTED AS A RESULT OF A REMEDIATION CAPA TO REASSESS PRODUCT RISKS. MANUFACTURER REFERENCE FILE # (B)(4).
Description of Event or Problem · 1
CUSTOMER REPORTED PATIENT HAD BLISTERS UNDER AREA COVERED BY THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 746902 | GRIP-LOK | GRIP-LOK LG FOLEY STERILE | KMK | TIDI PRODUCTS, LLC | 3400LFC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |