MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2018-07-27 for SENSIMATIC 500SE D500SE manufactured by Parkell, Inc..
[115189625]
Parkell received a subpoena from the state of (b)(6) to appear for deposition on july 6, 2018 for an incident that occurred on (b)(6) 2014 with a parkell 500se. Parkell had not been contacted by the patient or user prior to the subpoena. After appearing at the deposition, parkell decided to file this mdr. Per the subpoena: "the manner in which defendant, (b)(6), d. D. S. , used the electrosurge, which resulted in high heat production, causing damage to the surrounding soft tissue, bone, and loss of the dental implant. The resulting injury requires extensive surgical reconstruction. " there have been no other similar events or mdr reportable events related to the parkell sensimatic 500se. The parkell sensimatic 500se was manufactured from 1995-1999.
Patient Sequence No: 1, Text Type: N, H10
[115189626]
(b)(6), d. D. S. Used the electrosurge, which resulted in high heat production, causing damage to the surrounding soft tissue, bone, and loss of the dental implant.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2411797-2018-00001 |
| MDR Report Key | 7725524 |
| Report Source | OTHER |
| Date Received | 2018-07-27 |
| Date of Report | 2018-07-24 |
| Date of Event | 2014-03-17 |
| Date Mfgr Received | 2018-06-26 |
| Date Added to Maude | 2018-07-27 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 300 EXECUTIVE DRIVE |
| Manufacturer City | EDGEWOOD NY 11717 |
| Manufacturer Country | US |
| Manufacturer Postal | 11717 |
| Manufacturer Phone | 6312491134 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SENSIMATIC |
| Generic Name | ELECTROSURGICAL DEVICES |
| Product Code | EKZ |
| Date Received | 2018-07-27 |
| Model Number | 500SE |
| Catalog Number | D500SE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PARKELL, INC. |
| Manufacturer Address | 300 EXECUTIVE DRIVE EDGEWOOD NY 11717 US 11717 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-07-27 |