MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-07-11 for DISPOSABLE TECA CONCENTRIC NEEDLE S53153 manufactured by Natus Manufacturing Limited.
[49127599]
Review of device history record has been completed. No untoward issues in the manufacturing of lot 49e/15/t. Cert of irradiation was reviewed, all parameters are compliant and product in question was sterilised within the correct parameters. Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[49127600]
Patient developed cellulitus post procedure using teca concentric needle electrodes. Physician stated "the patient in question had an electromyography performed on the (b)(6) 2016. The needle session points were anterior tibialis, medical gastrocnemius, vastus lateralis as well as paraspinal. He reported a painful swollen inflamed leg, was treated with oral antibiotics and subsequently admitted for a diagnosis of cellulitis. When i saw him, the leg was typical of cellulitis, although it was not at the needle insertion points but the upper limit of the inflammation was approximately 5cm below the lowest of the insertion points. The insertion points in vastus lateralis and paraspinal muscles did not show any inflammation. The order of the needle insertion was from distal to proximal. The needle did not appear unusual, the packaging did not seem to have been tampered with and the performance of the test was the same as always. After hospitalisation, his infection is now completely cleared up, though there is still some swelling that persists in the leg. "
Patient Sequence No: 1, Text Type: D, B5
[61014784]
The following has been corrected: date of this report - corrected to 06/13/2016 (when reported to company) from 11/07/2016. Customer has been contacted to provide the rest of the required information. We are in the process of gathering additional information. A letter listing outstanding information has been sent to customer to obtain additional information in order to submit follow up report and/or explain why required information was not provided and steps taken to obtain such information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005581270-2016-00004 |
| MDR Report Key | 5781651 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-07-11 |
| Date of Report | 2016-06-13 |
| Date of Event | 2016-05-05 |
| Date Mfgr Received | 2016-06-13 |
| Device Manufacturer Date | 2015-11-30 |
| Date Added to Maude | 2016-07-11 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR MICHAEL GALVIN |
| Manufacturer Street | IDA BUSINESS PARK GORT |
| Manufacturer City | GALWAY, CONNAUGHT H91PD92 |
| Manufacturer Country | EI |
| Manufacturer Postal | H91PD92 |
| Manufacturer Phone | 9164700 |
| Manufacturer G1 | NATUS MANUFACTURING LIMITED |
| Manufacturer Street | IDA BUSINESS PARK GORT |
| Manufacturer City | GALWAY, CONNAUGHT H91PD92 |
| Manufacturer Country | EI |
| Manufacturer Postal Code | H91PD92 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DISPOSABLE TECA CONCENTRIC NEEDLE |
| Generic Name | ELECTRODE |
| Product Code | GXZ |
| Date Received | 2016-07-11 |
| Model Number | S53153 |
| Catalog Number | S53153 |
| Lot Number | 49F/15/T |
| Device Expiration Date | 2018-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATUS MANUFACTURING LIMITED |
| Manufacturer Address | IDA BUSINESS PARK GORT GALWAY, CONNAUGHT H91PD92 EI H91PD92 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-07-11 |