MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-12-22 for DYND802358 manufactured by Medline.
[1823875]
Pt sustained cut near scrotum due to very sharp edges (burs). Nine cases received (b)(6) 2010 returned to medline secondary to burs.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5018686 |
| MDR Report Key | 1938525 |
| Date Received | 2010-12-22 |
| Date of Report | 2010-12-13 |
| Date of Event | 2010-11-24 |
| Date Added to Maude | 2011-01-04 |
| 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 |
| Generic Name | MALE URINAL -GRADUATED URINAL WITH LID 32 OZ. |
| Product Code | FNP |
| Date Received | 2010-12-22 |
| Returned To Mfg | 2010-12-02 |
| Catalog Number | DYND802358 |
| Lot Number | 215510025-0053 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE |
| Generic Name | MALE URINAL -GRADUATED URINAL WITH LID 32 OZ |
| Product Code | FNP |
| Date Received | 2010-12-22 |
| Returned To Mfg | 2010-12-02 |
| Lot Number | 515610009-037 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-12-22 |