MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-03-31 for 7" GENTLETOUCH PILLOW 1937 manufactured by Mizuho Orthopedic Systems, Inc..
[826714]
During a lumbar lami w/fusion procedure (6+ hours) the patient was returned (two days later) to the operating room for a secondary procedure. It was noted that the patients forehead was red and signs of blistering. Patient stated that he believed it was the result of the surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2921578-2008-00006 |
| MDR Report Key | 1023631 |
| Report Source | 05 |
| Date Received | 2008-03-31 |
| Date of Report | 2008-03-28 |
| Date of Event | 2008-03-17 |
| Date Mfgr Received | 2008-03-17 |
| Date Added to Maude | 2009-05-05 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KIRKE JAYNE |
| Manufacturer Street | 30031 AHERN AVE. |
| Manufacturer City | UNION CITY CA 94587 |
| Manufacturer Country | US |
| Manufacturer Postal | 94587 |
| Manufacturer Phone | 5104768128 |
| Manufacturer G1 | MIZUHO ORTHOPEDIC SYSTEMS, INC. |
| Manufacturer Street | 30031 AHERN AVE. |
| Manufacturer City | UNION CITY CA 94587 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94587 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 7" GENTLETOUCH PILLOW |
| Generic Name | PILLOW |
| Product Code | KME |
| Date Received | 2008-03-31 |
| Model Number | 1937 |
| Catalog Number | 1937 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MIZUHO ORTHOPEDIC SYSTEMS, INC. |
| Manufacturer Address | 30031 AHERN AVE. UNION CITY CA 94578123 US 94578 1234 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2008-03-31 |