MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2007-04-05 for PROVOX LARYBUTTON UNK manufactured by Atos Medical Ab.
[783548]
Pt reinserted the product after cleaning. During the procedure, he accidentially pushed the product completely through the stoma into the trachea. The pt used a stainless steel forceps to retrieve the product. No other medical intervention was needed. However, the pt is a md. No complications occurred due to the incident, and the pt was able to reinsert the product correctly after the retrieval.
Patient Sequence No: 1, Text Type: D, B5
[8013688]
Stn: b077060.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8032044-2007-00002 |
| MDR Report Key | 957042 |
| Report Source | 04 |
| Date Received | 2007-04-05 |
| Date of Report | 2007-04-02 |
| Date of Event | 2006-12-19 |
| Date Added to Maude | 2007-12-04 |
| 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 | 0 |
| Manufacturer Street | PO BOX 183 |
| Manufacturer City | HORBY SE-242 22 |
| Manufacturer Country | SW |
| Manufacturer Postal | SE-242 22 |
| Manufacturer Phone | ** |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROVOX LARYBUTTON |
| Generic Name | TRACHEOSTOMA BUTTON |
| Product Code | ESE |
| Date Received | 2007-04-05 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 927579 |
| Manufacturer | ATOS MEDICAL AB |
| Manufacturer Address | PO BOX 183 HORBY SW SE-242 22 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-04-05 |