MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-01-22 for DAR 353/19004 manufactured by Mallinckrodt Dar Srl.
[175899784]
(b)(4). If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[175899785]
According to the reporter, the device was not having any visible damage, but the patients complained about breathlessness. There were no complications as they got connected to a new device immediately.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2936999-2020-00057 |
| MDR Report Key | 9616538 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-22 |
| Date of Report | 2020-03-19 |
| Date of Event | 2020-01-09 |
| Date Mfgr Received | 2020-02-24 |
| Device Manufacturer Date | 2019-11-08 |
| Date Added to Maude | 2020-01-22 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | AVI KLUGER |
| Manufacturer Street | 5920 LONGBOW DRIVE |
| Manufacturer City | BOULDER CO 80301 |
| Manufacturer Country | US |
| Manufacturer Postal | 80301 |
| Manufacturer Phone | 3035306582 |
| Manufacturer G1 | MALLINCKRODT DAR SRL |
| Manufacturer Street | VIA GIACOMO BOVE 2/4/6/8 |
| Manufacturer City | MIRANDOLA 41037 |
| Manufacturer Country | IT |
| Manufacturer Postal Code | 41037 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DAR |
| Generic Name | CONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE) |
| Product Code | BYD |
| Date Received | 2020-01-22 |
| Returned To Mfg | 2020-01-16 |
| Model Number | 353/19004 |
| Catalog Number | 353/19004 |
| Lot Number | 19K1050FAX |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MALLINCKRODT DAR SRL |
| Manufacturer Address | VIA GIACOMO BOVE 2/4/6/8 MIRANDOLA 41037 IT 41037 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-22 |