MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-05-25 for BLOM-SINGER manufactured by Freudenberg Medical, Llc.
[45957766]
Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[45957767]
Complaint was received from (b)(6) medical center from an slp that stated one of their patient's dislodged their prosthesis and the prosthesis/radiopaue ring was not visible under flouro or x-ray. The prosthesis was not found until approximately 1 month later, when the patient underwent a ct scan. The patient was quite ill during this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2025182-2016-00004 |
| MDR Report Key | 5680734 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-05-25 |
| Date of Report | 2016-05-25 |
| Date of Event | 2016-03-26 |
| Date Mfgr Received | 2016-05-02 |
| Date Added to Maude | 2016-05-25 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 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 PROSTHESIS |
| Product Code | EWL |
| Date Received | 2016-05-25 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | N |
| 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 | 2016-05-25 |