EASYTOUCH
Report
- Report Number
- 3005798905-2024-03181
- Event Type
- Injury
- Date Received
- May 2, 2024
- Date of Event
- May 2, 2024
- Report Date
- May 2, 2024
- Manufacturer
- FEEL TECH BIO CO., LTD.
- Product Code
- FMF
- PMA / PMN Number
- K102178
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- 003
Narratives
CMO WAS NOT ABLE TO LINK DEVICE MALFUNCTION TO MANUFACTURING, THUS, EFFECTIVENESS CHECK IS NOT APPLICABLE. PREVENTATIVE MEASURES, HOWEVER, WERE TAKEN - PER CAPA-24-2024 DUE TO SIMILARITIES IN COMPLAINTS FROM CAPA-24-2024 AND CAPA-26-2024 - I.E., ADJUSTING AIR PRESSURE IN NEEDLE SILICONE APPLICATION PROCESS AND INCREASED FREQUENCY OF AIR PRESSURE OPERATION STATUS INSPECTION, AND RETRAINING OF STAFF.
INITIAL TREND ANALYSIS FOR LOT 60204A WAS CONDUCTED, NO MALFUNCTIONS WERE FOUND. THIS IS THE ONLY COMPLAINT FOR LOT 60204A. FURTHER INVESTIGATION WILL BE CONDUCTED TO DETERMINE THE ROOT CAUSE OF COMPLAINT.
CMO WAS NOT ABLE TO LINK DEVICE MALFUNCTION TO MANUFACTURING, THUS, EFFECTIVENESS CHECK IS NOT APPLICABLE. PREVENTATIVE MEASURES, HOWEVER, WERE TAKEN - PER CAPA-24-2024 DUE TO SIMILARITIES IN COMPLAINTS FROM CAPA-24-2024 AND CAPA-26-2024 - I.E., ADJUSTING AIR PRESSURE IN NEEDLE SILICONE APPLICATION PROCESS AND INCREASED FREQUENCY OF AIR PRESSURE OPERATION STATUS INSPECTION, AND RETRAINING OF STAFF.
END USER REPORTED THAT WHILE REACHING INSIDE OF A BOX OF SYRINGES 830165 LOT 60204A THEIR HAND WAS PUNCTURED THROUGH THE POLYBAG. USER DID NOT SEEK MEDICAL ATTENTION DUE TO THE EVENT.
END USER REPORTED THAT WHILE REACHING INSIDE OF A BOX OF SYRINGES 830165 LOT 60204A THEIR HAND WAS PUNCTURED THROUGH THE POLYBAG. USER DID NOT SEEK MEDICAL ATTENTION DUE TO THE EVENT.
END USER REPORTED THAT WHILE REACHING INSIDE OF A BOX OF SYRINGES 830165 LOT 60204A THEIR HAND WAS PUNCTURED THROUGH THE POLYBAG. USER DID NOT SEEK MEDICAL ATTENTION DUE TO THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 847077 | EASYTOUCH | SYRINGE | FMF | FEEL TECH BIO CO., LTD. | 60204A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |