MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-22 for PROVOX 2 7218-01 manufactured by Atos Medical Ab.
[44371870]
Investigation of the returned device: the whole esophagus flange and valve of the prosthesis are torn away, i e the whole device is not returned. One part of the fraction surface is jagged and one part is smooth, indicating that a sharp instrument may have been used. The fraction surface does not have any candida and the silicone looks unaffected by any chemicals that could have caused the esophagus flange to rupture. Candida is seen at tracheal side of the prosthesis. Conclusion: judged from the complaint description, and the surface of the rupture it is not likely that this is a result of a faulty product. Kind regards, (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[44371871]
This is the information that has been received from atos medical local representative: pt returned to clinic and reported that he was experiencing difficulty talking following an episode of vomiting about 2 days prior. Te voicing was strained and effortful but at baseline voice is loud/good quality and speech is fluent. Last prosthesis change was (b)(6) 2016 at which time a provox 2 8mm voice prosthesis had been placed with no difficulty. Pt had tl in 2005 and no h/o rad tx and has been stable with use of this prosthesis size/type since that time. No h/o early prosthesis dysfunction and typically gets close to 1 year of device life. When examined, the prosthesis appeared to be protruding from the tep approx. 2 mm. The device was removed and part of the shaft and esophageal flange was absent. The pt denies manipulating, altering, or removing the device from the tep. The pt was resized w/o difficulty and was refitted with a 20 fr 14mm prosthesis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8032044-2016-00004 |
| MDR Report Key | 5597149 |
| Date Received | 2016-04-22 |
| Date of Report | 2016-04-22 |
| Date of Event | 2016-03-24 |
| Report Date | 2016-04-20 |
| Date Reported to Mfgr | 2016-04-20 |
| Date Mfgr Received | 2016-03-25 |
| Date Added to Maude | 2016-04-22 |
| 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 | MS. ELIN ALGOTSSON |
| Manufacturer Street | KRAFTGATAN 8 |
| Manufacturer City | HORBY, SE-24222 |
| Manufacturer Country | SW |
| Manufacturer Postal | SE-24222 |
| Manufacturer Phone | 641519800 |
| Manufacturer G1 | ATOS MEDICAL AB |
| Manufacturer Street | KRAFTGATAN 8 |
| Manufacturer City | HORBY, SE-24222 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | SE-24222 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PROVOX 2 |
| Generic Name | VOICE PROSTHESIS |
| Product Code | EWL |
| Date Received | 2016-04-22 |
| Returned To Mfg | 2016-04-15 |
| Catalog Number | 7218-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ATOS MEDICAL AB |
| Manufacturer Address | KRAFTGATAN 8 HORBY, SE-24222 SW SE-24222 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-04-22 |