MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-22 for FITGUARD SELECT NITRILE EXAM GLOVE FG2601 manufactured by Medline Industries Inc..
[63077761]
Patient Sequence No: 1, Text Type: N, H10
[63077762]
During donning of the gloves, easily ripped at top of the sleeve. Recurring problem at hospital.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6197978 |
| MDR Report Key | 6197978 |
| Date Received | 2016-12-22 |
| Date of Report | 2016-12-07 |
| Date of Event | 2016-11-11 |
| Report Date | 2016-12-07 |
| Date Reported to FDA | 2016-12-07 |
| Date Reported to Mfgr | 2016-12-07 |
| Date Added to Maude | 2016-12-22 |
| 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 GLOVE |
| Generic Name | POLYMER PATIENT EXAMINATION GLOVE |
| Product Code | LZA |
| Date Received | 2016-12-22 |
| Model Number | FG2601 |
| Catalog Number | FG2601 |
| Lot Number | EG608642733 |
| Device Availability | Y |
| 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 | 2016-12-22 |