MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-10-26 for CUFF, TRACHEAL TUBE, INFLATABLE manufactured by Mmj Sa De Cv (usd).
[90383150]
The customer did not retain the model or lot numbers which determine the 510k number and the manufacture date.
Patient Sequence No: 1, Text Type: N, H10
[90383211]
Medtronic received a report the physician experienced difficulty securing the cuff seal with the 7. 5 xtl shiley during a routine tracheostomy tube change. As reported, the patient received routine trach changes in intervals of every three months. Customer stated different trach sizes were tested before patient was successfully cannulated with the 6. 0 xlt shiley tube. Medtronic attempted to obtain additional information regarding the exact circumstances of this event; however the customer chose not to disclose any further information.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2936999-2017-05578 |
| MDR Report Key | 6981588 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-10-26 |
| Date of Report | 2017-10-26 |
| Date Mfgr Received | 2017-10-03 |
| Date Added to Maude | 2017-10-26 |
| 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 | SHARON MURPHY |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 2034925267 |
| Manufacturer G1 | MMJ SA DE CV (USD) |
| Manufacturer Street | AVE HENEQUEN NO 1181 DESARROLL |
| Manufacturer City | CIUDAD JUAREZ 32590 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 32590 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | CUFF, TRACHEAL TUBE, INFLATABLE |
| Product Code | BSK |
| Date Received | 2017-10-26 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MMJ SA DE CV (USD) |
| Manufacturer Address | AVE HENEQUEN NO 1181 DESARROLL CIUDAD JUAREZ 32590 MX 32590 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2017-10-26 |