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 2017-08-08 for MALLINCKRODT, 10FR STYLET/TRACHEAL TUBING 85864 manufactured by Mmj Sa De Cv (usd).
[82076589]
This device in this report is product code: bsr, device class: 1, regulation number: 868. 5790 (510k exempt). A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[82076590]
Medtronic received a report that the unit was having a labeling issue. It was incorrect. The issue was detected in the distribution center, therefore, there was no patient involved in this event. The customer discarded the product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2936999-2017-05394 |
| MDR Report Key | 6774831 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-08-08 |
| Date of Report | 2017-07-18 |
| Date of Event | 2017-07-18 |
| Date Mfgr Received | 2017-07-18 |
| Device Manufacturer Date | 2016-11-01 |
| Date Added to Maude | 2017-08-08 |
| 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,MEX 32590 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 32590 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MALLINCKRODT, 10FR STYLET/TRACHEAL TUBING |
| Generic Name | STYLET, TRACHEAL TUBE |
| Product Code | BSR |
| Date Received | 2017-08-08 |
| Model Number | 85864 |
| Catalog Number | 85864 |
| Lot Number | 16K0104JZX |
| 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,MEX 32590 MX 32590 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-08-08 |