MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2006-09-01 for XCP BITE-BLOCK 540861 manufactured by Dentsply Rinn.
[539020]
It was reported that a patient's tongue began to swell after a xcp bite-block was placed into the mouth. The patient was administered benadryl and the swelling subsided.
Patient Sequence No: 1, Text Type: D, B5
[7834486]
While it is unknown if the bite-block used in this case caused or contributed to the patient's symptoms, it is possible as allergic reactions to dental materials are known and reported, with medical consequences being dependent upon the severity of the individual allergic response and subsequent exposure to the same material. The device was returned, evaluated for endotoxin levels, and found to contain >=4. 8 and >9. 6 eu/device, under the pharmacopeia limit of 20 eu/device for pyrogen free devices. Also, the product family has been tested for irritation, sensitization, and cytotoxicity properties, with all tests passing the acceptance criteria. Additionally, the doctor stated that steam autoclaving is used for sterilization. The number of uses/sterilizations of the device is unknown. Please note that while the exact manufacture date is unknown, the device's white color indicates it was manufactured in or prior to 1998.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1418963-2006-00401 |
| MDR Report Key | 757140 |
| Report Source | 05 |
| Date Received | 2006-09-01 |
| Date of Report | 2006-08-03 |
| Date Mfgr Received | 2006-08-03 |
| Date Added to Maude | 2006-09-06 |
| 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 | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | DR PATRICIA KIHN |
| Manufacturer Street | 221 W. PHILA. ST., STE 60 |
| Manufacturer City | YORK PA 17404 |
| Manufacturer Country | US |
| Manufacturer Postal | 17404 |
| Manufacturer Phone | 7178457511 |
| Manufacturer G1 | DENTSPLY RINN |
| Manufacturer Street | 1212 ABBOTT DR |
| Manufacturer City | ELGIN IL 60123181 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60123 1819 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | XCP BITE-BLOCK |
| Generic Name | EGZ |
| Product Code | EGZ |
| Date Received | 2006-09-01 |
| Returned To Mfg | 2006-08-11 |
| Model Number | NA |
| Catalog Number | 540861 |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 745043 |
| Manufacturer | DENTSPLY RINN |
| Manufacturer Address | * ELGIN IL * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2006-09-01 |