MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2017-08-24 for BLOM-SINGER LP20-012 manufactured by Freudenberg Medical, Llc.
[83535159]
This report was originally submitted on 5/15/2017, 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
[83535160]
While investigating another previously reported event (b)(4), it was discovered that the patient had aspirated another prosthesis in (b)(6)2015. The device was a patient changeable voice prosthesis (b)(4); the exact lot number is unknown, however, it is either 0000002776 or 0000010285. The device was removed from the patient through bronchoscopy in (b)(6) 2015. The device was discarded and is not available for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2025182-2017-00002 |
| MDR Report Key | 6817222 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-08-24 |
| Date of Report | 2017-05-15 |
| Date of Event | 2015-12-15 |
| Date Mfgr Received | 2017-05-08 |
| Device Manufacturer Date | 2015-05-07 |
| 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 Country | US |
| 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 PROSTHESIS |
| Product Code | EWL |
| Date Received | 2017-08-24 |
| Catalog Number | LP20-012 |
| Lot Number | 0000002776/0000010285 |
| Device Expiration Date | 2018-03-19 |
| Operator | LAY USER/PATIENT |
| 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 |