MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-08-14 for STANDARD ADULT BITE BLOCK 100411 manufactured by Medivators.
[19926270]
Medivator bite blocks are causing minor cuts on the lips/mouth of patients during endoscopy procedures.
Patient Sequence No: 1, Text Type: D, B5
[20182365]
The case states that the medivators adult size bite blocks used in endoscope procedures were causing minor cuts on the lips/mouth of patients at this facility. There are no reported cases where the patient sought additional medical attention or experienced any long term effects as a result of these cuts to the mouth or lips. Medivators sales representative is in contact with the facility. This complaint will continue to be monitored within medivators complaint system.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1651395-2014-00004 |
| MDR Report Key | 4010520 |
| Report Source | 07 |
| Date Received | 2014-08-14 |
| Date of Report | 2014-08-14 |
| Date of Event | 2014-07-21 |
| Date Mfgr Received | 2014-07-21 |
| Date Added to Maude | 2014-08-14 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MEGAN DICKEY |
| Manufacturer Street | 14605 28TH AVE N |
| Manufacturer City | MINNEAPOLIS MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal | 55447 |
| Manufacturer Phone | 7635533327 |
| Manufacturer G1 | MEDIVATORS |
| Manufacturer Street | 3150 POLLOK DR |
| Manufacturer City | CONROE TX 77303 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 77303 |
| Single Use | 3 |
| Remedial Action | MA |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STANDARD ADULT BITE BLOCK |
| Generic Name | ENDOSCOPIC BITE BLOCK |
| Product Code | MNK |
| Date Received | 2014-08-14 |
| Model Number | 100411 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDIVATORS |
| Manufacturer Address | 3150 POLLOK DR CONROE TX 77303 US 77303 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-08-14 |