MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2006-10-06 for BIOPURE MTAD BP48R manufactured by Dentsply Tulsa.
[18514709]
It was reported that a patient became red, began to swell, and experienced pain immediately after biopure mtad was inadvertently delivered into the soft tissue via a perforation in the root, during root canal treatment. As a result, the tooth was extracted and antibiotics (augmentin) were administered. One week later, it was noted that the swelling was still present and the doctor indicated an intention to prescribe anti-inflammatory and pain medications. The doctor also plans on recommending that the patient be tested for tetracycline sensitivity.
Patient Sequence No: 1, Text Type: D, B5
[18685446]
Because antibiotics were prescribed and the tooth was extracted to preclude permanent damage to a body structure or permanent impairment of a body function and since 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, this event is reportable per 21 cfr part 803. As of this request, the device has not been returned for evaluated and the lot number is not available for retained-product testing and/or dhr review. If the lot number is provided, evaluation results will be submitted as they become available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2515379-2006-00419 |
| MDR Report Key | 767275 |
| Report Source | 05 |
| Date Received | 2006-10-06 |
| Date of Report | 2006-09-06 |
| Date of Event | 2006-09-06 |
| Date Mfgr Received | 2006-09-06 |
| Date Added to Maude | 2006-10-10 |
| 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 SUSQUEHANNA COMMERCE CENTER W. |
| Manufacturer City | YORK PA 17404 |
| Manufacturer Country | US |
| Manufacturer Postal | 17404 |
| Manufacturer Phone | 7178457511 |
| Manufacturer G1 | DENTSPLY CAULK |
| Manufacturer Street | 38 W. CLARKE AVE |
| Manufacturer City | MILFORD DE 19963 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19963 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOPURE MTAD |
| Generic Name | KJJ |
| Product Code | KJJ |
| Date Received | 2006-10-06 |
| Model Number | NA |
| Catalog Number | BP48R |
| Lot Number | NI |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 755173 |
| Manufacturer | DENTSPLY TULSA |
| Manufacturer Address | * JOHNSON CITY TN * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2006-10-06 |