MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-22 for ENCORE LATEX ACCLAIM LEFT GLOVE, SIZE 6 CE00086 manufactured by Ansell Healthcare Products Llc.
[137299792]
While inspecting the left glove prior to donning, two holes were found in the glove. The holes have the appearance of a punch hole and is in two layers of the folded glove. This occurred with two separate pairs of gloves from the same lot. Neither reached a patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5084328 |
| MDR Report Key | 8366827 |
| Date Received | 2019-02-22 |
| Date of Report | 2019-02-12 |
| Date of Event | 2019-02-05 |
| Date Added to Maude | 2019-02-25 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Brand Name | ENCORE LATEX ACCLAIM |
| Generic Name | SURGEON'S GLOVE |
| Product Code | KGO |
| Date Received | 2019-02-22 |
| Model Number | LEFT GLOVE, SIZE 6 |
| Catalog Number | CE00086 |
| Lot Number | 1712571504 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANSELL HEALTHCARE PRODUCTS LLC |
| Brand Name | ENCORE LATEX ACCLAIM |
| Generic Name | SURGEON'S GLOVES |
| Product Code | KGO |
| Date Received | 2019-02-22 |
| Model Number | LEFT GLOVE, SIZE 6 |
| Catalog Number | CE00086 |
| Lot Number | 1712571504 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | ANSELL HEALTHCARE PRODUCTS LLC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-22 |