MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-20 for GREEN GAMMEX PI ORTHO LF 70 GREEN PI ORTHO manufactured by Ansell Healthcare Products Llc.
[139298144]
Episode x 2 with gloves found to have holes while surgeons were wearing in surgical procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8435594 |
| MDR Report Key | 8435594 |
| Date Received | 2019-03-20 |
| Date of Report | 2019-03-18 |
| Date of Event | 2019-03-14 |
| Report Date | 2019-03-18 |
| Date Reported to FDA | 2019-03-18 |
| Date Reported to Mfgr | 2019-03-20 |
| Date Added to Maude | 2019-03-20 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | GREEN GAMMEX PI ORTHO LF 70 |
| Generic Name | SURGEON'S GLOVES |
| Product Code | KGO |
| Date Received | 2019-03-20 |
| Catalog Number | GREEN PI ORTHO |
| 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 | 2019-03-20 |