MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-02-10 for SHILEY 8PERC manufactured by Covidien Ag Juarez (mmj).
[178602796]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[178602797]
According to the reporter, the first item balloon was broken or damaged and the 2nd item balloon did not inflate. There was no allegation of patient death or serious injury associated with this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2936999-2020-00106 |
| MDR Report Key | 9687456 |
| Report Source | USER FACILITY |
| Date Received | 2020-02-10 |
| Date of Report | 2020-02-10 |
| Date of Event | 2020-01-01 |
| Date Mfgr Received | 2020-01-27 |
| Device Manufacturer Date | 2018-10-24 |
| Date Added to Maude | 2020-02-10 |
| 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 | COVIDIEN AG JUAREZ (MMJ) |
| Manufacturer Street | 1181 HENNEQUEN AVE. |
| Manufacturer City | JUAREZ,CHI 32575 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 32575 |
| 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 | 2020-02-10 |
| Model Number | 8PERC |
| Catalog Number | 8PERC |
| Lot Number | 18J0639JZX |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN AG JUAREZ (MMJ) |
| Manufacturer Address | 1181 HENNEQUEN AVE. JUAREZ,CHI 32575 MX 32575 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-10 |