N
Patient 1
MAUDE MDR 6325507
- MDR report key
- 6325507
- Report number
- 6325507
- Event key
- 0
- Event type
- 3
- Date of event
- 2017-01-16
- Date received
- 2017-02-13
- Adverse event
- 0
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Report source
- U
- Manufacturer link flag
- N
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NOVAPLUS | PLASTIC DISPOSAL URINAL | MEDLINE INDUSTRIES, INC. | FNP | NOVA20235 | NOVA20235 | N/A | * | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-02-13 | 0 | 1. O |
Event Narratives#
D
Patient 1
SHARP EDGE ON NEW PLASTIC URINAL CAUSED SKIN INJURY TO TWO PATIENTS ON TWO SEPARATE OCCASIONS. MANUFACTURER RESPONSE FOR PLASTIC DISPOSAL URINAL, NOVAPLUS (PER SITE REPORTER): ORIGINAL ADVICE WAS TO RETURN ITEMS OF CONCERN TO THEM FOR REPLACEMENT, WHICH THE HOSPITAL MATERIALS MANAGEMENT DEPARTMENT AT THE HOSPITAL DID. HOWEVER, WE WERE ADVISED THAT #275-4 REFLECTS THAT THIS URINAL WAS MANUFACTURED BY A SPECIFIC MACHINE. WE WERE ALSO ADVISED THAT WE WOULD CONTINUE TO RECEIVE URINALS MANUFACTURED BY THIS MACHINE IN THE FUTURE. WE WERE ALSO ADVISED THAT THE SHIPPING BOX WOULD CONTAIN URINALS MANUFACTURED BY MULTIPLE MACHINES AND ASSIGNED A LOT NUMBER ON THE OUTER BOX. THE HOSPITAL IS STOCKED WITH INDIVIDUAL URINALS THAT DO NOT REFLECT THE LOT NUMBER ON THE PRODUCT.