MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2017-08-24 for BLOM-SINGER BE 2018 manufactured by Freudenberg Medical, Llc.
[83517138]
This report was originally submitted on 12/14/2016, in an incorrect format. This was initially discovered on 8/23/2017, and this is being re-submitted on 8/24/2017.
Patient Sequence No: 1, Text Type: N, H10
[83517139]
Our (b)(4) distributor sent an email on november 29th, 2016 stating a patient had a device removed from their lungs. On (b)(6) 2016, while at home, the patient was in the process of inserting the patient changeable voice prosthesis when the device went into the patient's lungs. The patient went to the emergency room and had a chest x-ray which resulted in "no radiopaque or foreign object " found. On the following day, (b)(6) 2016, the patient underwent bronchoscopy where the device was found in the lungs and removed. There have been no further patient consequences reported due to this event. It was reported the patient followed the instructions for use when using this device. This was not the patient's first time using the device, and had been using this type of device since 2006.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2025182-2016-00008 |
| MDR Report Key | 6817243 |
| Report Source | DISTRIBUTOR |
| Date Received | 2017-08-24 |
| Date of Report | 2016-12-14 |
| Date of Event | 2016-11-28 |
| Date Mfgr Received | 2016-11-29 |
| Device Manufacturer Date | 2016-07-22 |
| Date Added to Maude | 2017-08-24 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. ALYSE MENCIAS |
| Manufacturer Street | 1110 MARK AVE |
| Manufacturer City | CARPINTERIA CA 93013 |
| Manufacturer Country | US |
| Manufacturer Postal | 93013 |
| Manufacturer Phone | 8055765414 |
| Manufacturer G1 | FREUDENBERG MEDICAL, LLC |
| Manufacturer Street | 1110 MARK AVE |
| Manufacturer City | CARPINTERIA CA 93013 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 93013 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BLOM-SINGER |
| Generic Name | VOICE PROTHESIS |
| Product Code | EWL |
| Date Received | 2017-08-24 |
| Catalog Number | BE 2018 |
| Lot Number | 0000037769 |
| Device Expiration Date | 2019-07-31 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FREUDENBERG MEDICAL, LLC |
| Manufacturer Address | 1110 MARK AVE CARPINTERIA CA 93013 US 93013 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-08-24 |