MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-16 for FITGUARD SELECT NITRILE EXAM GLOVES manufactured by Medline Industries, Inc..
[62550555]
Patient Sequence No: 1, Text Type: N, H10
[62550556]
While staff donning gloves, they easily ripped. Multiple complaints that these brand of gloves rip too easily or are found ripped when removed from the packaging, hospital has reported several cases.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6180722 |
| MDR Report Key | 6180722 |
| Date Received | 2016-12-16 |
| Date of Report | 2016-11-30 |
| Date of Event | 2016-11-04 |
| Report Date | 2016-11-30 |
| Date Reported to FDA | 2016-11-30 |
| Date Reported to Mfgr | 2016-11-30 |
| Date Added to Maude | 2016-12-16 |
| 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 | FITGUARD SELECT NITRILE EXAM GLOVES |
| Generic Name | POLYMER PATIENT EXAMINATION GLOVE |
| Product Code | LZA |
| Date Received | 2016-12-16 |
| Lot Number | KB608567530-1 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | ONE MEDLINE PL. MUNDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-12-16 |