MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-05-25 for SERVOX * manufactured by Servox Ag.
[531178]
Both repair jobs were billed to me as being repaired using original servox parts. I received them and could not voice right. People were having trouble understanding me. I did not have that much trouble before this company serviced the units. I found another medical supply that does service and they sent me the two evaluations of the service work that was done on the units. I must have a good working speech aid and it is very frustrating not to be understood. This is not an isolated case. I subscribe to a laryngectomee support group list and there is mention of similar happenings.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1035581 |
| MDR Report Key | 752487 |
| Date Received | 2005-05-25 |
| Date Added to Maude | 2006-08-22 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SERVOX |
| Generic Name | SERVOX SPEECH AID |
| Product Code | ESE |
| Date Received | 2005-05-25 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 740288 |
| Manufacturer | SERVOX AG |
| Manufacturer Address | P.O. BOX 920106 BIBERWEG 24-26 TROISDORF GM 5831 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-05-25 |