MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-16 for ISOFLEX LAL 2860 2860000000 manufactured by Stryker Medical London Dba Chg Hospital Beds.
[114138830]
It was alleged that the customer was experiencing a general increase in pressure injuries to patients while using stryker surfaces. No specific incident(s) were reported, and no details were provided regarding any possible medical intervention. Further, no defects were alleged with the units involved in the alleged events.
Patient Sequence No: 1, Text Type: D, B5
[116530027]
The customer did not make the units available for inspection and therefore the cause of the alleged injuries cannot be confirmed.
Patient Sequence No: 1, Text Type: N, H10
[116530028]
It was alleged that the customer was experiencing a general increase in pressure injuries to patients while using stryker surfaces. No specific incident(s) were reported, and no details were provided regarding any possible medical intervention. Further, no defects were alleged with the units involved in the alleged events.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001831750-2018-00669 |
| MDR Report Key | 7691803 |
| Date Received | 2018-07-16 |
| Date of Report | 2018-08-07 |
| Date of Event | 2018-06-18 |
| Date Mfgr Received | 2018-06-18 |
| Date Added to Maude | 2018-07-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. CHANDA BURGHARD |
| Manufacturer Street | 3800 EAST CENTRE AVENUE |
| Manufacturer City | PORTAGE MI 49002 |
| Manufacturer Country | US |
| Manufacturer Postal | 49002 |
| Manufacturer Phone | 2693292100 |
| Manufacturer G1 | STRYKER MEDICAL LONDON DBA CHG HOSPITAL BEDS |
| Manufacturer Street | 1020 ADELAIDE ST. S. |
| Manufacturer City | PORTAGE MI N6E 1R6 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | N6E 1R6 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ISOFLEX LAL 2860 |
| Generic Name | BED, FLOTATION THERAPY, POWERED |
| Product Code | IOQ |
| Date Received | 2018-07-16 |
| Catalog Number | 2860000000 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER MEDICAL LONDON DBA CHG HOSPITAL BEDS |
| Manufacturer Address | 1020 ADELAIDE ST. S. PORTAGE MI N6E 1R6 CA N6E 1R6 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-16 |