MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2017-06-30 for UNI-PATCH EP84265 manufactured by Covidien.
[78839703]
Submit date: 06/30/2017. An investigation is currently underway. Upon completion, the results will be forwarded. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[78839704]
The customer reported patient received skin irritation from electrode use. Open sore the size of a dime.
Patient Sequence No: 1, Text Type: D, B5
[108675838]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[109671472]
There were samples submitted with this complaint. Based on the returned product, the analysis did not confirm the reported condition or incident. The product did meet the product specifications. The hydrogel had minimal adhesion when touched wearing nitrile gloves. The pouch had two holes punched in the bottom, which could compromise the effectiveness of the tamper proof ziplock pouch and reduce the moisture in the hydrogel. All four used electrodes were impedance tested. The 2" x 3. 5" electrodes measured 75 and 72 ohms. The 2" x 2" electrodes measured 254 and 202 ohms. New electrodes have an upper specification of 150 ohms, so the 2" x 2" electrodes were above the specification for new electrodes. Impedance above 150 ohms on used electrodes is not uncommon and can be caused by contamination on the hydrogel or loss of moisture. The two electrodes that measured above 150 ohms were re-wet to assess moisture content and re-tested. During the re-test, the electrodes measured 124 and 135 ohms. The device history record (dhr) review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production pro cess. The investigation determined that the most probable root cause is due to improper application/re-application and storage of electrodes. Due to that fact that no complaint trend exists and a root cause for the reported condition cannot be specifically identified; therefore, corrective action will be limited to the manufacturing awareness. No further corrective action is required at this time. This complaint will be recorded for tracking and trending purposes. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183164-2017-05002 |
| MDR Report Key | 6681615 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2017-06-30 |
| Date of Report | 2018-01-03 |
| Date Mfgr Received | 2017-04-05 |
| Date Added to Maude | 2017-06-30 |
| 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 | EDWARD ALMEIDA |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524151 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | 1313 W GRANT BLVD |
| Manufacturer City | WABASHA MN 55981 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55981 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNI-PATCH |
| Generic Name | ELECTRODE, CUTANEOUS |
| Product Code | GXY |
| Date Received | 2017-06-30 |
| Returned To Mfg | 2017-05-15 |
| Model Number | EP84265 |
| Catalog Number | EP84265 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 1313 W GRANT BLVD WABASHA MN 55981 US 55981 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-06-30 |