MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2017-06-29 for PROVOX LARYTUBE 9/55 7607 manufactured by Atos Medical Ab.
[78698686]
This is an initial report. The device has not been returned from the patient, so the investigation has not yet been started. However this is a new phenomenon that we have not seen before. All devices are inspected after injection molding and then manually handled in production before sent to customer so this is deemed as an isolated event and will be investigated as soon as the product has been returned.
Patient Sequence No: 1, Text Type: N, H10
[78698687]
This is the information that was received from the atos medical local representative: the product was in 6 weeks from purchase, pt removed one pm to clean and noticed piece missing at that time she coughed and felt something fly out (assumption the missing piece). Actual date of event not recalled, item bought at the (b)(6) clinic (b)(6) 2017. Pt used h2o & hydrogen peroxide for cleaning as per teaching. Pt uses water based lubricant to ease insertion.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8032044-2017-00010 |
| MDR Report Key | 6676473 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2017-06-29 |
| Date of Report | 2017-05-10 |
| Date of Event | 2017-05-10 |
| Date Facility Aware | 2017-05-10 |
| Date Mfgr Received | 2017-10-05 |
| Device Manufacturer Date | 2016-03-18 |
| Date Added to Maude | 2017-06-29 |
| 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 | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. KAROLINA NILSSON |
| 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 | 3 |
| Brand Name | PROVOX LARYTUBE 9/55 |
| Generic Name | LARYNGECTOMY TUBE |
| Product Code | KAC |
| Date Received | 2017-06-29 |
| Returned To Mfg | 2017-07-18 |
| Catalog Number | 7607 |
| Lot Number | 1606018 |
| Device Expiration Date | 2019-02-28 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | 1 YR |
| 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 | 2017-06-29 |