MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2011-06-20 for BIVONA SILICONE EPISTAXIS CATHETER EP0050 manufactured by Smiths Medical Asd, Inc..
[2075472]
User facility reported that the product was in use. According to reporter, the distal cuff could not be deflated to allow removal from patient. Patient was given anesthesia and the distal cuff was deflated using a needle under arthroscopy. No permanent adverse effects reported.
Patient Sequence No: 1, Text Type: D, B5
[9153562]
Customer has not yet returned the device to the manufacturer for device evaluation. When and if the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183502-2011-00491 |
| MDR Report Key | 2142307 |
| Report Source | 01,05,06 |
| Date Received | 2011-06-20 |
| Date of Report | 2011-06-17 |
| Report Date | 2011-06-17 |
| Date Reported to FDA | 2011-06-17 |
| Date Mfgr Received | 2011-05-20 |
| Device Manufacturer Date | 2010-09-01 |
| Date Added to Maude | 2011-06-30 |
| 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 |
| Reporter Occupation | PHARMACIST |
| 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 ASD, INC. |
| Manufacturer Street | 5700 WEST 23RD AVE. |
| 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 | BIVONA SILICONE EPISTAXIS CATHETER |
| Generic Name | EMX - BALLOON, EPISTAXIS |
| Product Code | EMX |
| Date Received | 2011-06-20 |
| Model Number | NA |
| Catalog Number | EP0050 |
| Lot Number | 1842450 |
| ID Number | NA |
| Device Expiration Date | 2015-08-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 8 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL ASD, INC. |
| Manufacturer Address | GARY IN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-06-20 |