MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-12 for GEL ONE SYRINGE manufactured by Zimmer, Inc..
[184155308]
Spontaneous: patient advised that she had brought the gel-one into the doctor? S office for the injection. She reported that as soon as the doctor started the injection, the medications started to leak out of the syringe and barely any was injected into the knee before the doctor has to stop due to sterility concerns. Patient did not have the lot or expiration date available as everything was being kept at the doctor? S office. No additional side effects were reported as a result of this. Reported to (b)(6) by: patient/caregiver.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093729 |
| MDR Report Key | 9829045 |
| Date Received | 2020-03-12 |
| Date of Report | 2020-03-02 |
| Date Added to Maude | 2020-03-13 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GEL ONE SYRINGE |
| Generic Name | ACID, HYALURONIC, INTRAARTICULAR |
| Product Code | MOZ |
| Date Received | 2020-03-12 |
| Device Availability | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER, INC. |
| Brand Name | 30MG/3ML |
| Product Code | --- |
| Date Received | 2020-03-12 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-12 |