MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-02 for SURGICLICK 26-012 manufactured by Deroyal Industries, Inc..
[87860284]
Patient Sequence No: 1, Text Type: N, H10
[87860285]
As the surgeon and surgical tech placed sterile light handles covers on or lights. However both covers split and contaminated the sterile gloves worn.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6906656 |
| MDR Report Key | 6906656 |
| Date Received | 2017-10-02 |
| Date of Report | 2017-09-18 |
| Date of Event | 2017-09-08 |
| Report Date | 2017-09-11 |
| Date Reported to FDA | 2017-09-11 |
| Date Reported to Mfgr | 2017-09-11 |
| Date Added to Maude | 2017-10-02 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SURGICLICK |
| Generic Name | LIGHT, SURGICAL, ACCESSORIES |
| Product Code | FTA |
| Date Received | 2017-10-02 |
| Catalog Number | 26-012 |
| Lot Number | 44368851 |
| Operator | PHYSICIAN |
| Device Availability | * |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEROYAL INDUSTRIES, INC. |
| Manufacturer Address | 200 DEBUSK LN. POWELL TN 37849 US 37849 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-02 |