MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-09-21 for BIOPURE MTAD BP48R manufactured by Dentsply Tulsa.
[723854]
It was reported that a patient experienced swelling and soreness in the area of a tooth in which biopure was used. The tooth was extracted as a result of the reaction and patient discomfort.
Patient Sequence No: 1, Text Type: D, B5
[7865013]
While it is unk if the biopure 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 sams material. The lot number was provided, though evaluation results are not available as of this report. Evaluation results will be submitted as they become available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2515379-2007-00156 |
| MDR Report Key | 916857 |
| Report Source | 05 |
| Date Received | 2007-09-21 |
| Date of Report | 2007-08-23 |
| Date of Event | 2007-08-16 |
| Date Mfgr Received | 2007-08-23 |
| Device Manufacturer Date | 2006-12-01 |
| Date Added to Maude | 2007-09-26 |
| 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 | HELEN LEWIS |
| Manufacturer Street | SUSQUEHANNA COMMERCE CENTER W. 221 W. PHILA. ST., STE. 60 |
| Manufacturer City | YORK PA 17401 |
| Manufacturer Postal | 17401 |
| Manufacturer Phone | 7178457511 |
| Manufacturer G1 | DENTSPLY CAULK |
| Manufacturer Street | 38 WEST CLARKE AVE. |
| Manufacturer City | MILFORD DE 19963 |
| Manufacturer Postal Code | 19963 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOPURE MTAD |
| Product Code | KJJ |
| Date Received | 2007-09-21 |
| Model Number | NA |
| Catalog Number | BP48R |
| Lot Number | 061201 |
| ID Number | NA |
| Device Expiration Date | 2008-12-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 891189 |
| Manufacturer | DENTSPLY TULSA |
| Manufacturer Address | JOHNSON CITY TN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-09-21 |