MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2017-09-18 for MADAJET XL 401 401013632XLM manufactured by Mada Medical Products, Inc..
[86439518]
Mada learned of a possible serious injury involving a madajet when it was served with a lawsuit brought by the patient against her treating physician and mada on (b)(6) 2017. Initial discovery provided to mada in connection with the lawsuit indicated that the needle free injector that was involved in the patient's injuries was a dermojet, which is not a mada product. However, on 6/26/2017, at the inspection of the treating physician's needle-free injectors, the treating physician presented a madajet rather than a dermojet. Since discovery is currently underway in the lawsuit, mada does not yet have all available data.
Patient Sequence No: 1, Text Type: N, H10
[86439519]
Per patient's lawsuit, on (b)(6) 2014, patient underwent lower lid blepharoplasty, brow/forehead lift and dermal grafts. On (b)(6) 2014, patient presented with a scar of the central upper portion of the lower right eyelid. A needle-free injector was used to inject a steroid (kenalog) to treat the scar. Thereafter, patient complained of visual loss and blurriness.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2225311-2017-00001 |
| MDR Report Key | 6871735 |
| Report Source | OTHER |
| Date Received | 2017-09-18 |
| Date of Report | 2017-07-28 |
| Date of Event | 2014-05-27 |
| Date Facility Aware | 2017-04-27 |
| Date Mfgr Received | 2017-04-27 |
| Device Manufacturer Date | 2006-05-10 |
| Date Added to Maude | 2017-09-18 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | MR. JEFFREY ADAM |
| Manufacturer Street | 625 WASHINGTON AVENUE |
| Manufacturer City | CARLSTADT NJ 07072 |
| Manufacturer Country | US |
| Manufacturer Postal | 07072 |
| Manufacturer Phone | 2014600454 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MADAJET XL |
| Generic Name | NEEDLE FREE INJECTOR |
| Product Code | EGM |
| Date Received | 2017-09-18 |
| Model Number | 401 |
| Catalog Number | 401013632XLM |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MADA MEDICAL PRODUCTS, INC. |
| Manufacturer Address | 625 WASHINGTON AVENUE CARLSTADT NJ 07072 US 07072 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2017-09-18 |