MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-13 for KLS MARTIN TRANSBUCCAL MODULE 55-961-20 manufactured by Kls Martin L.p..
[89292210]
Patient Sequence No: 1, Text Type: N, H10
[89292231]
Patient case for a mandible fracture. Provider was using a kls martin transbuccal module on the patient's mandible. Provider reported that a screw in the base of the instrument opening (where an obturator inserts) prevented the instrument from properly retracting. The provider apparently cut his left index finger on the screw while attempting to use the instrument. Provider was seen in employee health for injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6947942 |
| MDR Report Key | 6947942 |
| Date Received | 2017-10-13 |
| Date of Report | 2017-09-25 |
| Date of Event | 2017-09-19 |
| Report Date | 2017-09-25 |
| Date Reported to FDA | 2017-09-25 |
| Date Reported to Mfgr | 2017-09-25 |
| Date Added to Maude | 2017-10-13 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KLS MARTIN TRANSBUCCAL MODULE |
| Generic Name | MODULE, TRANSBUCCAL |
| Product Code | HAO |
| Date Received | 2017-10-13 |
| Model Number | TRANSBUCCAL MODULE |
| Catalog Number | 55-961-20 |
| Operator | PHYSICIAN |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KLS MARTIN L.P. |
| Manufacturer Address | 11201 SAINT JOHNS INDUSTRIAL PKWY S JACKSONVILLE FL 32246 US 32246 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-10-13 |