MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-05-30 for HENRY SCHEIN PRESSURE INDICATING PASTE 1721101FG manufactured by Dentsply Caulk.
[4617905]
In this event it was reported that a pt experienced an allergic reaction after using henry schein pressure indicating paste. According to the doctor, the pt was treated in (b)(6) 2012 for a procedure using the pressure indicating paste. Immediately after the treatment, the customer developed a red mark on her lip which is still present. The pt has been seeing a dermatologist since (b)(6) 2012 and recently had a biopsy done to determine what chemical she is reacting to.
Patient Sequence No: 1, Text Type: D, B5
[12063379]
While it is unknown if the device 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. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device was not returned for eval and the lot number was not provided for retained-product testing and/or dhr review.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2515379-2014-00031 |
| MDR Report Key | 3855176 |
| Report Source | 05 |
| Date Received | 2014-05-30 |
| Date of Report | 2014-04-30 |
| Date of Event | 2012-03-01 |
| Date Mfgr Received | 2014-04-30 |
| Date Added to Maude | 2014-06-10 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | HELEN LEWIS |
| Manufacturer Street | 221 W. PHILADELPHIA ST., STE 60 |
| Manufacturer City | YORK PA 17401 |
| Manufacturer Country | US |
| Manufacturer Postal | 17401 |
| Manufacturer Phone | 7178457511 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HENRY SCHEIN PRESSURE INDICATING PASTE |
| Generic Name | ARTICULATION PAPER |
| Product Code | EFH |
| Date Received | 2014-05-30 |
| Catalog Number | 1721101FG |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DENTSPLY CAULK |
| Manufacturer Address | MILFORD DE US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-05-30 |