MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-18 for GAMMEX NON LATEX manufactured by Ansell Healthcare Products Llc.
[142338114]
Operating room rn brought open package of sterile gloves that scrub tech was intending to put on to prep or table. Scrub tech immediately noted hair within glove packaging. Tech did not don gloves. Patient was not in room. Compromised gloves were removed from room. New gloves were opened and supplies and instruments were opened appropriately.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8526686 |
| MDR Report Key | 8526686 |
| Date Received | 2019-04-18 |
| Date of Report | 2019-04-04 |
| Date of Event | 2019-04-04 |
| Report Date | 2019-04-04 |
| Date Reported to FDA | 2019-04-04 |
| Date Reported to Mfgr | 2019-04-18 |
| Date Added to Maude | 2019-04-18 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | GAMMEX NON LATEX |
| Generic Name | SURGEON'S GLOVES |
| Product Code | KGO |
| Date Received | 2019-04-18 |
| Lot Number | 1809062605 |
| Device Availability | * |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANSELL HEALTHCARE PRODUCTS LLC |
| Manufacturer Address | 1635 INDUSTRIAL RD. DOTHAN AL 36303 US 36303 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-18 |