MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2014-12-01 for EPISTAXIS CATHETER EP0050 manufactured by Smiths Medical Inc..
[5223321]
The distributor reported on behalf of the user facility that the device was in use with pt (general condition and health of the pt was described as poor) for 12 hours when cuff deflation was observed. It was reported that the pt suffered hemorrhagic shock and passed away. It is unk at this time if the deflated cuff is correlated to the death of the pt. Further info has been requested. No further info has been received at this time.
Patient Sequence No: 1, Text Type: D, B5
[12708270]
Customer has not yet returned the device to the mfr for device eval. When and if the device becomes available and is returned and evaluated the mfr will file a follow-up report detailing the results of the eval. This info was entered into the mfrs complaint database for tracking and reporting purposes.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183502-2014-00913 |
| MDR Report Key | 4332492 |
| Report Source | 01,06 |
| Date Received | 2014-12-01 |
| Date of Report | 2014-11-26 |
| Report Date | 2014-11-26 |
| Date Reported to FDA | 2014-11-26 |
| Date Mfgr Received | 2014-10-30 |
| Device Manufacturer Date | 2014-01-23 |
| Date Added to Maude | 2014-12-17 |
| 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 | PETE HIRTE |
| Manufacturer Street | 1265 GREY FOX RD. |
| Manufacturer City | ST. PAUL MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 6516287384 |
| Manufacturer G1 | SMITHS MEDICAL MD, INC. |
| Manufacturer Street | 5700 WEST 23RD AVENUE |
| Manufacturer City | GARY IN 46406 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46406 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EPISTAXIS CATHETER |
| Product Code | EMX |
| Date Received | 2014-12-01 |
| Model Number | NA |
| Catalog Number | EP0050 |
| Lot Number | 2575018 |
| ID Number | NA |
| Device Expiration Date | 2018-12-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 11 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL INC. |
| Manufacturer Address | GARY IN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2014-12-01 |