MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-09-06 for BLOM-SINGER IN 1607-SL manufactured by Freudenberg Medical, Llc.
[85086852]
Patient Sequence No: 1, Text Type: N, H10
[85086853]
The complainant initially reported a complaint of leakage and the device was returned for evaluation. A letter was received with the returned device reporting that the patient was hospitalized for a week with possible pneumonia. Follow-up with the complainant was performed; the complainant believes that the possible pneumonia was caused by the leakage of the voice prosthesis. The complainant does not know if there was a confirmed medical diagnosis of pneumonia for the patient. Additionally, the complainant indicated that the patient was treated with a "very strong antibiotic. " it was also mentioned that the treating physician advised that the patient's chest x-ray was "cloudy. " follow-up with the treating physician could not be performed because the name and contact information of the treating physician were not available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2025182-2017-00006 |
| MDR Report Key | 6847174 |
| Report Source | CONSUMER |
| Date Received | 2017-09-06 |
| Date of Report | 2017-09-06 |
| Date of Event | 2017-07-07 |
| Date Mfgr Received | 2017-08-21 |
| Device Manufacturer Date | 2017-05-05 |
| Date Added to Maude | 2017-09-06 |
| 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 | JONATHAN LEE |
| Manufacturer Street | 1110 MARK AVENUE |
| Manufacturer City | CARPINTERIA CA 93013 |
| Manufacturer Country | US |
| Manufacturer Postal | 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 | 2017-09-06 |
| Returned To Mfg | 2017-08-12 |
| Catalog Number | IN 1607-SL |
| Lot Number | 0000064938 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FREUDENBERG MEDICAL, LLC |
| Manufacturer Address | 1110 MARK AVENUE CARPINTERIA CA 93013 US 93013 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2017-09-06 |