MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-01-22 for POLY SCREW DRIVER RETEN SLEEVE 2020-00-401 202000401 manufactured by Medos International Sàrl Ch.
[176645657]
If the information is unknown, not available or does not apply, the section/field of the form is left blank. Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. Without a lot number the device history records review could not be completed. Product was not returned. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[176645658]
It was reported that on an unknown date, the poly screwdriver shaft was getting stuck inside of the holding sleeve. Procedure outcome is unknown. There were no patient consequences. This report is for a poly screw driver retention sleeve. This is report 1 of 2 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1526439-2020-00425 |
| MDR Report Key | 9616633 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-22 |
| Date of Report | 2020-01-08 |
| Date Mfgr Received | 2020-02-10 |
| Date Added to Maude | 2020-01-22 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARA DITTY-BOVARD |
| Manufacturer Street | CHEMIN-BLANC 38 |
| Manufacturer City | LE LOCLE 02400 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 02400 |
| Manufacturer Phone | 6103142063 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POLY SCREW DRIVER RETEN SLEEVE |
| Generic Name | CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY |
| Product Code | GEA |
| Date Received | 2020-01-22 |
| Model Number | 2020-00-401 |
| Catalog Number | 202000401 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDOS INTERNATIONAL SàRL CH |
| Manufacturer Address | CHEMIN-BLANC 38 LE LOCLE 02400 SZ 02400 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-22 |