MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-02 for PAIN TRAY/KIT / CUSTOM ANESTHESIA TRAY DYNJRA1118 manufactured by Medline Industries, Inc..
[132210799]
Performing a pain injection on patient. Needle used broke off from the hub of the needle into the patient. Needle retrieved by physician.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5082762 |
| MDR Report Key | 8212541 |
| Date Received | 2019-01-02 |
| Date of Report | 2018-12-29 |
| Date of Event | 2018-12-11 |
| Date Added to Maude | 2019-01-03 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PAIN TRAY/KIT / CUSTOM ANESTHESIA TRAY |
| Generic Name | PAIN TRAY/KIT / CUSTOM ANESTHESIA TRAY |
| Product Code | OGD |
| Date Received | 2019-01-02 |
| Catalog Number | DYNJRA1118 |
| Lot Number | 18FBA666 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-01-02 |