MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-30 for SHILEY 8DCT manufactured by Mmj Sa De Cv(usd).
[186674878]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[186674879]
According to the reporter, the device's cuff had an audible leak. It was stated that the device had to be replaced.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2936999-2020-00233 |
| MDR Report Key | 9896678 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-03-05 |
| Date Mfgr Received | 2020-03-10 |
| Device Manufacturer Date | 2019-07-25 |
| Date Added to Maude | 2020-03-30 |
| 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 | MMJ SA DE CV(USD) |
| Manufacturer Street | AVE HENEQUEN NO 1181 DESARROL |
| Manufacturer City | CIUDAD JUAREZ,MX 32590 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 32590 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SHILEY |
| Generic Name | TUBE TRACHEOSTOMY AND TUBE CUFF |
| Product Code | JOH |
| Date Received | 2020-03-30 |
| Returned To Mfg | 2020-03-19 |
| Model Number | 8DCT |
| Catalog Number | 8DCT |
| Lot Number | 19G0784JZX |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MMJ SA DE CV(USD) |
| Manufacturer Address | AVE HENEQUEN NO 1181 DESARROL CIUDAD JUAREZ,MX 32590 MX 32590 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-30 |