MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-16 for EAR ULCER SYRINGE RI13CSI DGN00280 manufactured by Medline Industries, Inc..
[145223047]
The respiratory therapist opened the sterile package to use the bulb syringe and noted that the seam around the bulb part was not fused together.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8615217 |
| MDR Report Key | 8615217 |
| Date Received | 2019-05-16 |
| Date of Report | 2019-05-14 |
| Date of Event | 2019-05-10 |
| Report Date | 2019-05-14 |
| Date Reported to FDA | 2019-05-14 |
| Date Reported to Mfgr | 2019-05-16 |
| Date Added to Maude | 2019-05-16 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EAR ULCER SYRINGE |
| Generic Name | SYRINGE, ENT |
| Product Code | KCP |
| Date Received | 2019-05-16 |
| Model Number | RI13CSI |
| Catalog Number | DGN00280 |
| Lot Number | 96918030001 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | ONE MEDLINE PL. MUNDELEIN IL 600604489 US 600604489 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-16 |