MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-10-30 for manufactured by Na.
[958343]
Physical check. Nurse gave me a plastic bottle with lid for collecting urine sample. The lid was too tight to get open. On the top of the lid is a paper label asking patient not to remove it. I peeled the label to see if there is a locking mechanism to open the bottle. There is no warning that a sharp is equipped. It poked my finger and caused bleeding. This product is not safe to be used, lacking adequate warning and safeguard feature.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5008833 |
| MDR Report Key | 1217526 |
| Date Received | 2008-10-30 |
| Date of Report | 2008-10-30 |
| Date of Event | 2008-10-14 |
| Date Added to Maude | 2008-11-07 |
| 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 | PATIENT |
| 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 | NA |
| Generic Name | NA |
| Product Code | LIO |
| Date Received | 2008-10-30 |
| Model Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1268127 |
| Manufacturer | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2008-10-30 |