D
Patient 1
IT WAS REPORTED THE PATIENT'S SKIN BROKE DOWN ON THE MATTRESS. THE WOUND CARE SPECIALIST REPORTED THE WOUND WAS TREATED WITH MESALT AND ALLEVYN.
MAUDE MDR 6801628
- MDR report key
- 6801628
- Report number
- 0001831750-2017-00339
- Event key
- 0
- Event type
- 3
- Date of event
- 2017-07-13
- Date received
- 2017-08-17
- 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 | ISOFLEX LAL 2860 | BED, FLOTATION THERAPY, POWERED | STRYKER MEDICAL-KALAMAZOO | IOQ | 2860000000 | N | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-08-17 | 0 |
Event Narratives#
N
Patient 1
IT WAS IT WAS IDENTIFIED THAT THE CUSTOMER HAD ASSUMED THAT ISOFLEX LAL (A GEL SUPPORT SURFACE) WAS AN AIR MATTRESS RATHER THAN A GEL MATTRESS. IT WAS IDENTIFIED THAT AN AIR MATTRESS MAY BE BETTER SUITED FOR THIS ACCOUNT'S NEEDS. THE CUSTOMER'S ISOFLEX LAL UNITS WERE REPLACED WITH ISOAIR UNITS (AN AIR SUPPORT SURFACE).
D
Patient 1
IT WAS REPORTED THE PATIENT'S SKIN BROKE DOWN ON THE MATTRESS. THE WOUND CARE SPECIALIST REPORTED THE WOUND WAS TREATED WITH MESALT AND ALLEVYN.