N
Patient 1
THE MATTRESS IS BEING RETURNED TO STRYKER FOR EVALUATION. THE CUSTOMER WILL RECEIVE A REPLACEMENT UNIT.
MAUDE MDR 6956460
- MDR report key
- 6956460
- Report number
- 0001831750-2017-00456
- Event key
- 0
- Event type
- 3
- Date of event
- 2017-09-21
- Date received
- 2017-10-17
- 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 | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-10-17 | 0 |
Event Narratives#
D
Patient 1
IT WAS REPORTED THE CUSTOMER DEVELOPED A HOSPITAL ACQUIRED PRESSURE INJURY WHILE ON THE MATTRESS.
N
Patient 1
THE UNIT WAS RETURNED TO STRYKER. UPON RETURN, THE UNIT WAS EVALUATED BY A STRYKER QUALITY ASSURANCE ENGINEER. NO DEFECTS WERE FOUND UPON EVALUATION. FURTHER CONVERSATION WITH THE CUSTOMER FOUND THAT THE PATIENT WAS A (B)(6) WOMAN WHO WAS ADMITTED FOR A WHIPPLE PROCEDURE DUE TO PANCREATIC ADENOCARCINOMA. SHE ALSO REPORTEDLY HAD DIABETES WHICH WAS "UNDER CONTROL" AND WAS A NONSMOKER. THE CUSTOMER STATED THAT THEY REPOSITIONED THE PATIENT EVERY TWO HOURS WHEN SHE ALLOWED, HOWEVER THE PATIENT DID REFUSE REPOSITIONING AT TIMES. THE CUSTOMER CLASSIFIED THE INJURY AS A STAGE 2 PRESSURE INJURY. THE ISSUE WAS RESOLVED FOR THE CUSTOMER BY STRYKER CLINICAL NURSE CONSULTING DISCUSSING PROPER PRESSURE INJURY MANAGEMENT TECHNIQUES WITH THE CUSTOMER.
D
Patient 1
IT WAS REPORTED THE CUSTOMER DEVELOPED A HOSPITAL ACQUIRED PRESSURE INJURY WHILE ON THE MATTRESS.