FDA Adverse Event
Summary report: N
INJECTION GUN SET-60CC ADAPTOR FOR BD & MONOJECT SYRINGES, STAINLESS, AUTOCLAVAB
MDR report key: 15550572
·
Received October 5, 2022
Report
- Report Number
- MW5112460
- Date Received
- October 5, 2022
- Report Date
- October 5, 2022
- Manufacturer
- MEDCO MANUFACTURING, LLC/MEDCO MFG.
- Product Code
- GEA
- Report Source
- Voluntary report
- Reporter Occupation
- UNKNOWN
- Health Professional
- *
Narratives
Description of Event or Problem · 0
IFU (INSTRUCTIONS FOR USE) FROM COMPANY DOES NOT PROVIDE A STERILIZATION THAT IS AVAILABLE ON A STANDARD STERILIZER. COMPANY WILL NOT RETURN MY CALL OR STERILIZER REP CALL. MY BOSS SAYS STERILIZE IT SOMEHOW; I CAN'T WITHOUT IFU. THEY WON'T CALL BACK. FDA PLEASE FIX THIS. ON (B)(6) 2022: CALLED FOR UPDATED IFU. LEFT MESSAGE WITH SERVICE; "(B)(6)" LET "(B)(6)" KNOW NO RESPONSE. NOT A REAL SETTING ON ANY BRAND: "BELIMED", STERIS, OR GETINGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1577024 | INJECTION GUN SET-60CC ADAPTOR FOR BD & MONOJECT SYRINGES, STAINLESS, AUTOCLAVAB | CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY | GEA | MEDCO MANUFACTURING, LLC/MEDCO MFG. | 14854 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | STERILIZER |