MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-04-04 for MALLINCKRODT 85864 manufactured by Mmj Sa De Cv (usd).
[104429466]
This device in this report is product code: bsr, device class: 1 regulation number: 868. 5790 (510k exempt). If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[104429467]
According to the reporter, the anesthesiologist forwarded an email which states he believes this stylet part number 85864 is "too short and flimsy". It was reported that this product is "inferior" due to not providing enough support and the outer covering being too slick. There was no injury reported associated with this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2936999-2018-00230 |
| MDR Report Key | 7398023 |
| Report Source | USER FACILITY |
| Date Received | 2018-04-04 |
| Date of Report | 2018-04-04 |
| Date Mfgr Received | 2018-03-06 |
| Date Added to Maude | 2018-04-04 |
| 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 | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 3035306582 |
| 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 |
| Brand Name | MALLINCKRODT |
| Generic Name | STYLET, TRACHEAL TUBE |
| Product Code | BSR |
| Date Received | 2018-04-04 |
| Model Number | 85864 |
| Catalog Number | 85864 |
| 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 | 2018-04-04 |