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 2020-03-20 for SHILEY SSV manufactured by Mallinckrodt Dar Srl.
[184262170]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[184262171]
According to the reporter, the device had defective valve. The customer stated that, as routinely, the spouse has replaced the old one after a month, and replaced it with a new device, this has been done and as it was installed, the patient has raised hands to point out that he is suffocating. The spouse removed the new device and he started to breath properly. The wife replaced and put back the old device and no issues were noticed. After several days the spouse wanted to try the supposed defected device again, and thus, replaced it and again the husband could hardly breath.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2936999-2020-00220 |
| MDR Report Key | 9859599 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-20 |
| Date of Event | 2020-02-06 |
| Date Mfgr Received | 2020-03-04 |
| Device Manufacturer Date | 2019-05-17 |
| Date Added to Maude | 2020-03-20 |
| 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 | 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 | SHILEY |
| Generic Name | TUBE, TRACHEOSTOMY (W/WO CONNECTOR) |
| Product Code | BTO |
| Date Received | 2020-03-20 |
| Returned To Mfg | 2020-03-13 |
| Model Number | SSV |
| Catalog Number | SSV |
| Lot Number | 19D0858FAX |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2020-03-20 |