MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-04-16 for MEDLINE REF CUR8315 manufactured by Medline Mundelein.
[1142656]
Laboratory employee, while putting on size medium curad nitrile powder-free glove, sustained minor laceration from pointed shard of clear glass inside the glove in the ring finger; no permanent disability to employee from minor laceration. Forty five cases of medium gloves with same lot number removed from shelves.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5010798 |
| MDR Report Key | 1365328 |
| Date Received | 2009-04-16 |
| Date of Report | 2009-04-16 |
| Date of Event | 2009-04-02 |
| Date Added to Maude | 2009-05-06 |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDLINE |
| Generic Name | MEDIUM CURAD NITRILE POWDER-FREE GLOVE |
| Product Code | LZC |
| Date Received | 2009-04-16 |
| Catalog Number | REF CUR8315 |
| Lot Number | ME803969009 |
| ID Number | DATE 09-2008 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE MUNDELEIN |
| Manufacturer Address | MUNDELEIN IL 60060448 US 60060 4486 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-04-16 |