MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2015-05-26 for PROVOX ACTIVALVE 7152 manufactured by Atos Medical Ab.
[5831212]
The clinician explained that when inserting the valve, and pushing the blue inserter pin in, the blue ring of the activalve came loose and detached from the silicon corpus of the valve. The clinician did not notice any excessive force whilst doing this, as they thought it could be to do with the way the oesophageal flange was folded into the inserter. This particular clinician has a lot of experience using this particular valve and was concerned that there could be a manufacturing issue. The inner blue ring of the valve became detached from the end of the inserter pin and was retrieved from the oesophagus. The patient was not affected by the event and has now a replacement valve.
Patient Sequence No: 1, Text Type: D, B5
[13299766]
Investigation: ring and flap are separated from the housing. The hinge has also been ruptured. Safety strap is intact. These damages do not appear if insertion is made according to the ifu. Investigation shows that the ring and the housing have been glued as intended, no air bubbles in the glue. In the areas of the ring and the flap some kind of substance seems to have been added, likely some type of lubricant-gel. The added lubricant suggests that the clinician faced some kind of problem during insertion. Conclusion: the complaint report states that the blue ring came loose at the time of insertion (the safety strap is still attached). Most likely, a wrong method was used during insertion. This resulted in a separated prosthesis. This is based on the fact that it was glued from beginning and that the hinge was ruptured no product fault, use error. Action: the user should be instructed to read the ifu to secure a proper handling when inserting the activalve.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8032044-2015-00006 |
| MDR Report Key | 4794359 |
| Report Source | 05,07 |
| Date Received | 2015-05-26 |
| Date of Report | 2015-05-26 |
| Date of Event | 2015-04-28 |
| Date Mfgr Received | 2015-04-28 |
| Device Manufacturer Date | 2014-08-01 |
| Date Added to Maude | 2015-06-23 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR FERENC DAHNER |
| Manufacturer Street | PO-BOX 183 |
| 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 2 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | SE-242 22 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROVOX ACTIVALVE |
| Generic Name | LARYNGEAL VOICE PROSTHESIS |
| Product Code | EWL |
| Date Received | 2015-05-26 |
| Returned To Mfg | 2015-05-22 |
| Catalog Number | 7152 |
| Lot Number | 1408076 |
| Device Expiration Date | 2019-07-01 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ATOS MEDICAL AB |
| Manufacturer Address | PO BOX 183 KRAFTGATAN 8 HORBY, SE-242 2 SW SE-242 22 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-05-26 |