MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-08-24 for BLOM-SINGER IN 1614-NS manufactured by Freudenberg Medical, Llc.
[83548940]
This report was originally submitted on 8/10/2017, 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
[83548941]
A complaint of an aspirated prosthesis not showing up on x-ray was reported by the patient's speech language pathologist (slp). The slp additionally reported that the "prosthesis was visualized in the patient's bronchus on a tracheal scope" and that the prosthesis "did not show up on x-ray, even with 7 views. " the x-rays were reviewed by a radiologist, attending ent, resident ent, and the slp. A full bronchoscopy was performed on the patient to remove the aspirated prosthesis and to check if a previously displaced device was aspirated. It was confirmed that the previously displaced device had been swallowed and only 1 device was aspirated. It was confirmed that the devices did not contribute to the aspiration event nor the previous event of swallowing, and that these events were related to the patient's granulation tissue. The complaintant indicated that the device was discarded and thus would not be returned for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2025182-2017-00003 |
| MDR Report Key | 6817229 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-08-24 |
| Date of Report | 2017-08-10 |
| Date of Event | 2017-07-12 |
| Date Mfgr Received | 2017-07-14 |
| Device Manufacturer Date | 2015-11-05 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| 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 G1 | FREUDENBERG MEDICAL |
| 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 PROSTHESIS |
| Product Code | EWL |
| Date Received | 2017-08-24 |
| Catalog Number | IN 1614-NS |
| Lot Number | 0000011020 |
| Device Expiration Date | 2018-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 |