FDA Adverse Event
Other
Summary report: N
ISOSAF ENFIT ORAL LIQUID SYRINGE
MDR report key: 18383702
·
Received December 21, 2023
Report
- Report Number
- MW5149464
- Event Type
- Other
- Date Received
- December 21, 2023
- Report Date
- October 19, 2023
- Manufacturer
- GBUK GROUP LIMITED
- Product Code
- PNR
- Report Source
- Voluntary report
- Reporter Occupation
- UNKNOWN
- Health Professional
- *
Narratives
Description of Event or Problem · 0
RECEIVED AN ENFIT ORAL LIQUID SYRINGES THAT ARE NOT MARKED APPROPRIATELY. THE SYRINGES ARE MADE BY ISOSAF. LOT NUMBER IS C03200001. ISMP, 5200 BUTLER PIKE, PLYMOUTH MEETING, PA 19462. PHONE: 215-947-7797. EMAIL: [email protected]. SUBMISSION ID 87957.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2263952 | ISOSAF ENFIT ORAL LIQUID SYRINGE | ENTERAL SYRINGES WITH ENTERAL SPECIFIC CONNECTORS | PNR | GBUK GROUP LIMITED | C03200001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |