MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-03-14 for ADULT BITE BLOCK-LATEX FREE 000429 manufactured by Consolidated Medical Equipment Company.
[102323108]
The device was not returned for evaluation by the user facility, therefore; the reported failure could not be verified and a root cause cannot be conclusively determined. A review of the manufacturing documents verified the device was produced per current and approved procedures and material specifications. Non-conformances regarding the product's identity, quality, safety, effectiveness or performance were not identified at the time of manufacture. A two-year review of complaint history revealed one other similar complaint for this product family and failure mode. In that same timeframe, (b)(4) units of this product family have been sold worldwide, making the rate of occurrence of this failure (b)(4)percent, should all complaints be confirmed. No failure mode was reported for this device by the user facility, therefore; a risk analysis was unable to be conducted due to lack of a failure mode of the device. The instructions for use advises the user of the following. - removal of dentures or partial dental plates is recommended per physician's directions. This issue will continue to be monitored through the complaint system to assure patient safety.
Patient Sequence No: 1, Text Type: N, H10
[102323109]
The user facility reported that an upper endoscopy procedure with the 000429 bite block resulted in damage to the patient's dentition. The four teeth in the lower frontal region were noticed to be dislodged. There was no procedural delay associated with this incident. Upon gathering additional information, it was noted that the patient had the dental history of missing upper molars bilaterally and poor dentition. The patient was discharged home and required additional work on affected teeth due to this event. This report is raised on the basis of a reported patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007305485-2018-00055 |
| MDR Report Key | 7337388 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-03-14 |
| Date of Report | 2018-03-14 |
| Date of Event | 2017-11-27 |
| Date Mfgr Received | 2018-02-19 |
| Device Manufacturer Date | 2018-01-16 |
| Date Added to Maude | 2018-03-14 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. MARTHA CAMACHO URRIBARRI |
| Manufacturer Street | 525 FRENCH ROAD |
| Manufacturer City | UTICA NY 13502 |
| Manufacturer Country | US |
| Manufacturer Postal | 13502 |
| Manufacturer Phone | 3156243051 |
| Manufacturer G1 | CONMED CORPORATION |
| Manufacturer Street | 525 FRENCH ROAD |
| Manufacturer City | UTICA NY 13502 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 13502 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADULT BITE BLOCK-LATEX FREE |
| Generic Name | SCOPE SAVER DISPOSABLE BITEBLO |
| Product Code | KTI |
| Date Received | 2018-03-14 |
| Model Number | 000429 |
| Catalog Number | 000429 |
| Lot Number | 201801164 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONSOLIDATED MEDICAL EQUIPMENT COMPANY |
| Manufacturer Address | AVE. ALEJANDRO DUMAS NO. 11321 COMPLEJO INDUSTRIAL CHIHUAHUA CHIHUAHUA CP 1136 MX CP 1136 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-03-14 |