MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-03-09 for BIOPURE MTAD BP48R manufactured by Dentsply Tulsa.
[574385]
It was reported that biopure mtad material contacted a pt's lip during an endodontic procedure. The pt immediately reported a burning sensation and the lip began to swell. As a result, the pt was sent to the er and was administered four shots, two of which were benadryl and prednisone. The next morning, the swelling reportedly had progressed to the right side of the face past the center line and up toward the eye. Two days following the event, the pt returned to the er and was administered iv and oral antibiotics in addition to oral benadryl and prednisone; the treating dr expressed some doubt over whether the symptoms were the result of an allergic reaction due to the lack of response to the treatments administered, the symptoms reportedly improved following the second er visit, though four days following the initial reaction the symptoms were reported to have worsened. Several days later, the pt had the tooth extracted due to buccal bone loss (no buccal plate). The initial reporter stated that the oral surgeon was "pretty certain that the pt was affected by sodium hypochlorite. It would have attacked the lip first. The pt seems to be getting a bit better, but with all the medications for allergic reactions that they gave him, he should have gotten better pretty quickly. "
Patient Sequence No: 1, Text Type: D, B5
[7818558]
While it is unk if the biopure used in this case caused or contributed to the pt'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. Please note that the pt has reportedly made a full recovery. A returned sample was visually inspected, evaluated for chemical properties, and found to be in spec. The product involved in the event is available for eval, though has not been returned as of this report. Further eval results will be submitted as they become available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2515379-2007-00065 |
| MDR Report Key | 827640 |
| Report Source | 05 |
| Date Received | 2007-03-09 |
| Date of Report | 2007-02-08 |
| Date of Event | 2007-02-05 |
| Date Mfgr Received | 2007-02-08 |
| Device Manufacturer Date | 2006-09-01 |
| Date Added to Maude | 2007-03-15 |
| 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 | 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 | 2007-03-09 |
| Model Number | NA |
| Catalog Number | BP48R |
| Lot Number | 060927 |
| ID Number | NA |
| Device Expiration Date | 2008-02-07 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 815037 |
| Manufacturer | DENTSPLY TULSA |
| Manufacturer Address | * JOHNSON CITY TN * US |
| Baseline Brand Name | BIOPURE MTAD |
| Baseline Generic Name | KJJ |
| Baseline Model No | NA |
| Baseline Catalog No | BP48R |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-03-09 |