MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2013-04-18 for TEN20 10-20-8 manufactured by D.o. Weaver And Company.
[21672664]
Pt had a sleep study at the (b)(6) center, beginning at 9pm on (b)(6) 2013 and ending at 6am on (b)(6) 2013. Pt said his skin was prepped with nuprep skin prep gel, and that the technicians scrubbed his skin very hard, to the point of causing pain. Pt stated that he was unable to fall asleep, so he was given a sleeping pill, and afer a few hours, was still unable to fall asleep so he was given a second sleeping pill. Pt stated that he was still very drowsy when he drove himself home after the study. When he arrived at his residence, his vision was quite blurry and his skin was itchy and stinging. He said he experienced burning, itching, and blistering around his scalp, and his eyes and lips were swollen and dry. The skin irritation and blurred vision continued and he was not relieved, he drove himself to the er at (b)(6) hospital, around 9pm on (b)(6) 2013.
Patient Sequence No: 1, Text Type: D, B5
[21905524]
Pt stated this was his second sleep study at this facility, and he encountered no problems during the first study. We recommended to the pt that he see a dermatologist. We followed up with the pt on (b)(4) 2013. He said that he had seen a dermatologist, and that the dermatologist gave him prescriptions to treat his reaction. Pt said the swelling around his eyes was diminished, but still there, and that his skin peeling. He said he is scheduled to see the dermatologist against in a week or so. Pt stated that he was seeking legal advise and would like compensation from us. Complaint has been turned over to insurance company, who will be conducing all further follow up with the pt. Pt likely experienced some sort of allergic reaction, either from our product (nuprep and ten20), or from something else during the sleep study, such as the sleeping pills. We will submit a follow up report if we receive additional relevant info pertaining to this case. Pt is expected to recover. We requested the device be returned to us by the user facility. However, they declined, stating that they were required to keep the device there since the pt also filed a complaint at the facility.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1718791-2013-00004 |
| MDR Report Key | 3266536 |
| Report Source | 00 |
| Date Received | 2013-04-18 |
| Date of Report | 2013-04-15 |
| Date of Event | 2013-03-15 |
| Date Mfgr Received | 2013-03-18 |
| Device Manufacturer Date | 2011-07-26 |
| Date Added to Maude | 2013-08-07 |
| 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 | MR NICHOLAS LEE |
| Manufacturer Street | 565 NUCLA WAY UNIT B |
| Manufacturer City | AURORA CO 80011 |
| Manufacturer Country | US |
| Manufacturer Postal | 80011 |
| Manufacturer Phone | 3033661804 |
| Manufacturer G1 | D.O. WEAVER AND COMPANY |
| Manufacturer Street | 565 NUCLA WAY UNIT B |
| Manufacturer City | AURORA CO 80011 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80011 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TEN20 |
| Generic Name | TEN20 CONDUCTIVE PASTE |
| Product Code | GYB |
| Date Received | 2013-04-18 |
| Model Number | 10-20-8 |
| Catalog Number | 10-20-8 |
| Lot Number | 126 |
| Device Expiration Date | 2014-07-31 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | D.O. WEAVER AND COMPANY |
| Manufacturer Address | 565 NUCLA WAY UNIT B AURORA CO 80011 US 80011 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2013-04-18 |