D
Patient 1
IT WAS REPORTED A PATIENT'S SKIN BROKE DOWN WHILE ON THE MATTRESS.
MAUDE MDR 8126800
- MDR report key
- 8126800
- Report number
- 0001831750-2018-01447
- Event key
- 0
- Event type
- 3
- Date of event
- 2018-11-03
- Date received
- 2018-12-03
- 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. MARY KLAVER
- 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 | 2018-12-03 | 0 |
Event Narratives#
N
Patient 1
IT WAS REPORTED TO THE ACCOUNT MANAGER THAT THE ACCOUNT PLACED AN EHOB OVERLAY UNDERNEATH THE PATIENT, ON TOP OF THE MATTRESS, FOLLOWING THE DISCOVERY OF THE INJURY. THE PATIENT WAS DISCHARGED THE NEXT DAY AND THE ACCOUNT DID NOT SPEAK OF ANY MEDICAL TREATMENT FOR THE ALLEGED INJURY. A REVIEW OF PHOTOS OF THE REPORTED INJURY BY A STRYKER CLINICAL NURSE CONSULTANT, FOUND THAT SHE BELIEVED THE PATIENT HAD SHOWN DISCOLORATION IN THE SHAPE OF THE GEL THAT RESEMBLES REACTIVE HYPEREMIA. NO MALFUNCTION OR DEFECT WAS ALLEGED. SERIAL NUMBER OF THE UNIT WAS NOT RECORDED.
D
Patient 1
IT WAS REPORTED A PATIENT'S SKIN BROKE DOWN WHILE ON THE MATTRESS.