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 2018-03-26 for MALLINCKRODT 85864 manufactured by Mmj, S.a. De C.v.(usd).
[103460773]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[103460774]
According to the reporter, the anesthesiologist forwarded an email which stated that the device contributed to the death of the patient. The device was too short and flimsy. The reporter could not provide the date of death.
Patient Sequence No: 1, Text Type: D, B5
[105952335]
(b)(4). If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[106053536]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2936999-2018-00190 |
| MDR Report Key | 7370373 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-03-26 |
| Date of Report | 2018-04-12 |
| Date Mfgr Received | 2018-03-06 |
| Date Added to Maude | 2018-03-26 |
| 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 | AVI KLUGER |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 3035306582 |
| Manufacturer G1 | MMJ, S.A. DE C.V.(USD) |
| Manufacturer Street | AVE. HENEQUEN NO 1181 DESARROL |
| Manufacturer City | CIUDAD JUAREZ,CI 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 | 2018-03-26 |
| Model Number | 85864 |
| Catalog Number | 85864 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MMJ, S.A. DE C.V.(USD) |
| Manufacturer Address | AVE. HENEQUEN NO 1181 DESARROL CIUDAD JUAREZ,CI 32590 MX 32590 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2018-03-26 |