MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-31 for CURAD CUR9225 manufactured by Medline.
[76289511]
Patient Sequence No: 1, Text Type: N, H10
[76289512]
Curad non-sterile vinyl gloves have been ripping when staff don them as personal protective equipment.
Patient Sequence No: 1, Text Type: D, B5
[86151666]
Patient Sequence No: 1, Text Type: N, H10
[86151667]
Curad non-sterile vinyl gloves have been ripping when staff don't them as personal protective equipment. The hospital believes the gloves has been discontinued by the manufacturer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6600794 |
| MDR Report Key | 6600794 |
| Date Received | 2017-05-31 |
| Date of Report | 2017-05-12 |
| Date of Event | 2017-05-03 |
| Report Date | 2017-05-12 |
| Date Reported to FDA | 2017-05-12 |
| Date Reported to Mfgr | 2017-05-12 |
| Date Added to Maude | 2017-05-31 |
| 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 | CURAD |
| Generic Name | VINYL PATIENT EXAMINATION GLOVE |
| Product Code | LYZ |
| Date Received | 2017-05-31 |
| Model Number | CUR9225 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE |
| Manufacturer Address | ONE MEDLINE PL. MUNDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-31 |