D
Patient 1
IT WAS REPORTED THAT THE PATIENT WAS SITTING ON THE EDGE OF THE UNIT AND SLID OFF. THERE WAS PATIENT INVOLVEMENT, HOWEVER NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.
MAUDE MDR 7430868
- MDR report key
- 7430868
- Report number
- 0001831750-2018-00200
- Event key
- 0
- Event type
- 3
- Date of event
- 2018-02-27
- Date received
- 2018-04-13
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MR. CHANDA BURGHARD
- Address
- 3800 EAST CENTRE AVENUE PORTAGE MI 49002 US
- Phone
- 269-269-2693
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN_MEDICAL_PRODUCT | BED, FLOTATION THERAPY, POWERED | STRYKER MEDICAL-KALAMAZOO | IOQ | UNK_MED | N | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2018-04-13 | 0 |
Event Narratives#
N
Patient 1
DURING THE COURSE OF THE INVESTIGATION IT WAS FOUND THAT THE MATTRESS IS NOT MANUFACTURED OR DISTRIBUTED BY STRYKER. DEVICE NOT MANUFACTURED BY STRYKER.
D
Patient 1
IT WAS REPORTED THAT THE PATIENT WAS SITTING ON THE EDGE OF THE UNIT AND SLID OFF. THERE WAS PATIENT INVOLVEMENT, HOWEVER NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.