MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-02 for PROVOX NID 17 FR, 8 MM 7102 manufactured by Atos Medical Ab.
[32784592]
Product have not been returned, examination is not possible. It is indicated that the prosthesis have been exposed to excessive force since the esophagus flange was ruptured and continuous insertions with a gel cap by the patient. In the provox capsule ifu it is stated that the product is only to be used by clinicians (other gelcaps are not allowed to be used).
Patient Sequence No: 1, Text Type: N, H10
[32784593]
According to the complaint description; "patient reported that voice prosthesis extruded at home, she had voice prosthesis but continued coughing. She suctioned herself and noted that she suctioned the central dark blue stabilizing piece of the prosthesis from her trachea. When the voice prosthesis was brought into the clinic it was noted that the esophageal flange was torn along its attachment to the voice prosthesis shaft. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8032044-2015-00010 |
| MDR Report Key | 5260227 |
| Date Received | 2015-12-02 |
| Date of Report | 2015-12-02 |
| Date of Event | 2015-10-20 |
| Date Mfgr Received | 2015-10-27 |
| Date Added to Maude | 2015-12-02 |
| 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 MARIE LANGE |
| Manufacturer Street | PO-BOX 183 KRAFTGATAN 8 |
| Manufacturer City | HORBY, SE-242 22 |
| Manufacturer Country | SW |
| Manufacturer Postal | SE-242 22 |
| Manufacturer Phone | 415 19800 |
| Manufacturer G1 | ATOS MEDICAL AB |
| Manufacturer Street | PO BOX 183 KRAFTGATAN 8 |
| Manufacturer City | HORBY, SE-242 22 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | SE-242 22 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PROVOX NID 17 FR, 8 MM |
| Generic Name | VOICE PROSTHESIS, LARYNGEAL (TAUB) |
| Product Code | EWL |
| Date Received | 2015-12-02 |
| Catalog Number | 7102 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ATOS MEDICAL AB |
| Manufacturer Address | PO BOX 183 KRAFTGATAN 8 HORBY, SE-242 22 SW SE-242 22 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-12-02 |