MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2011-06-15 for HENRY SCHEIN SOFTLINE CHAIRSIDE RELINE KIT 100-3029 manufactured by Septodont Confi-dental Division.
[2069516]
According to (b)(6), office manager for (b)(6), a female patient experienced a sudden rise in blood pressure while the reline material was being used and was transported to the hospital by ambulance. They administered the product and after about a minute, she complained of being dizzy - they gave her some water and she felt better - they started again and again she was dizzy - the blood pressure readings taken were 201/138; 217/121; and 217/143. She gave them permission to call an ambulance and have her transported to the hospital where she was admitted. They spoke to her a few days later and advised her to see an allergist to find out what caused this rise in blood pressure, but she refused stating "who is going to pay for this? I cannot afford to go to another doctor. " they requested the transcripts from the hospital, but she refused to sign the release. This was the first time this product was used on her. They use it every day on other patients and have had no problem. The box and product was given to the ems so the lot code is not available. He will record lot numbers in the future.
Patient Sequence No: 1, Text Type: D, B5
[9166701]
This product has been used in dentistry for many years. To date, we have never had another complaint or report of blood pressure complications associated with this product. The customer, (b)(6), indicated that "no product is being returned for evaluation". As of the date of submission of this report, no samples of the suspect product had been received and the lot number of the product in question could not be determined. Dr. (b)(6), was consulted. He was unaware of any such hypertension response from dental applications of this material.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1721729-2011-00001 |
| MDR Report Key | 2141063 |
| Report Source | 05,08 |
| Date Received | 2011-06-15 |
| Date of Report | 2011-06-14 |
| Date of Event | 2011-04-28 |
| Date Mfgr Received | 2011-05-27 |
| Date Added to Maude | 2012-06-18 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | GARY LEFFLER, MANAGER |
| Manufacturer Street | 416 SOUTH TAYLOR AVE. |
| Manufacturer City | LOUISVILLE CO 80027 |
| Manufacturer Country | US |
| Manufacturer Postal | 80027 |
| Manufacturer Phone | 3036657535 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HENRY SCHEIN SOFTLINE CHAIRSIDE RELINE KIT |
| Generic Name | DENTAL DENTURE RELINE MATERIAL |
| Product Code | EBC |
| Date Received | 2011-06-15 |
| Catalog Number | 100-3029 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SEPTODONT CONFI-DENTAL DIVISION |
| Manufacturer Address | 416 SOUTH TAYLOR AVE. LOUISVILLE CO 80027 US 80027 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2011-06-15 |