MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-06-14 for VERSA PRO EXAM GLOVES * manufactured by *.
[2768325]
Reporter called on behalf of her son. She stated her son is a recent tracheostomy pt. She says she uses exam gloves to clean the site. She stated she opened a new box and after using a few gloves? She pulled one out that appeared contaminated. She reported that a fingertip of a glove had a yellow/brownish foreign substance on it, possibly came in contact with a liquid. Reporter stated her son has been suffering from infections, but she? S not sure if the infections are related to the gloves. She said she stopped using the box of gloves and her son was put on antibiotics and is doing much better now. She stated she is using another brand of gloves now and has had no problems with infections.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5025774 |
| MDR Report Key | 2617558 |
| Date Received | 2012-06-14 |
| Date of Report | 2012-06-14 |
| Date Added to Maude | 2012-06-18 |
| 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 | 0 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VERSA PRO EXAM GLOVES |
| Generic Name | EXAM GLOVES/100 PER BOX |
| Product Code | LYY |
| Date Received | 2012-06-14 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 34-GG-888 |
| ID Number | * |
| Operator | OTHER |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | * |
| Manufacturer Address | * * CH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-06-14 |