MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-17 for BLOM-SINGER IN 4064 manufactured by Freudenberg Medical, Llc.
[92463297]
On (b)(6) 2017, the patient's speech language pathologist (slp) reported a complaint of an aspirated cleaning brush tip. The cleaning brush tip became detached from the handle while the patient was cleaning their voice prosthesis. The patient did not realize that they had aspirated the product. In the following weeks, the patient's health deteriorated, and after repeated visits to the clinic, doctors were able to conclude that there was a foreign object lodged in the patient's windpipe. Follow-up with the slp indicated that the aspiration event occurred a few weeks before (b)(6) 2017; however, the slp was not able to provide additional details about any treatment or intervention performed for the patient (e. G. Removal). The slp did indicate that the patient is presently in a healthy state. Additionally, the slp indicated that the cleaning brush was not available to return for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2025182-2017-00007 |
| MDR Report Key | 7043087 |
| Date Received | 2017-11-17 |
| Date of Report | 2017-11-15 |
| Date of Event | 2017-10-01 |
| Date Mfgr Received | 2017-10-29 |
| Date Added to Maude | 2017-11-17 |
| 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 | 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 | 0 |
| Brand Name | BLOM-SINGER |
| Generic Name | CLEANING BRUSH |
| Product Code | EPE |
| Date Received | 2017-11-17 |
| Catalog Number | IN 4064 |
| 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 AVENUE CARPINTERIA CA 93013 US 93013 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-11-17 |