MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-12-10 for HYDRO-CAST TISSUE TREATMENT UNK manufactured by Dentsply Caulk.
[21724742]
In this event it was reported that a pt inadvertently swallowed a small amount of hydro-cast tissue conditioning material and immediately experienced a burning sensation in her throat. The pt was referred to a physician and no further details are available at this time.
Patient Sequence No: 1, Text Type: D, B5
[22148243]
While there is no indication that the device malfunctioned in this event, because intervention was required, this event meets the criteria for reportability per 21 cfr part 803. The device was not returned for evaluation 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 | 2515379-2014-00081 |
| MDR Report Key | 4336055 |
| Report Source | 05 |
| Date Received | 2014-12-10 |
| Date of Report | 2014-11-11 |
| Date of Event | 2014-11-11 |
| Date Mfgr Received | 2014-11-11 |
| Date Added to Maude | 2014-12-18 |
| 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 SUSQUEHANNA COMMERCE CENTER W |
| 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 | HYDRO-CAST TISSUE TREATMENT |
| Generic Name | RESIN, DENTURE, RELINING, REPAIRING |
| Product Code | EBI |
| Date Received | 2014-12-10 |
| Catalog Number | UNK |
| 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. Required No Informationntervention | 2014-12-10 |