MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2019-04-12 for SHEARGUARD CHEST PAD COVERS 5844-12 manufactured by Mizuho Orthopedic Systems, Inc..
[141763660]
Unable to determine if the patient had comorbidities that could have contributed to the problem. Advised the distributor to discuss the owner's manual positioning instructions with the customer. This problem was initially reported as related to the proaxis table. Investigation found it might also be related to the two single-use pad covers, so two additional reports are being filed showing the possible association of the injury with those two devices.
Patient Sequence No: 1, Text Type: N, H10
[141763661]
Patient was positioned prone for posterior approach surgery utilizing the standard proaxis spine assembly (open frame/spars) configured with torso trolley, arm boards, chest/pelvic bolsters and leg support. All items were covered prior to the procedure with the recommended osi shear protect consumables to minimize risk of skin injury. Postoperatively, the client presented with pressure related sores under areas of contact around sternum and asis. It was noted that bmi and length of case (up to 13 hours) could have been contributing factors.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2921578-2019-00015 |
| MDR Report Key | 8509085 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2019-04-12 |
| Date of Report | 2019-08-28 |
| Date of Event | 2019-01-08 |
| Date Mfgr Received | 2019-04-02 |
| Date Added to Maude | 2019-04-12 |
| 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 | ANNE LEBLANC |
| Manufacturer Street | 30031 AHERN AVENUE |
| Manufacturer City | UNION CITY CA 945871234 |
| Manufacturer Country | US |
| Manufacturer Postal | 945871234 |
| Manufacturer Phone | 5104291500 |
| Manufacturer G1 | MIZUHO ORTHOPEDIC SYSTEMS, INC. |
| Manufacturer Street | 30031 AHERN AVENUE |
| Manufacturer City | UNION CITY CA 945871234 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 945871234 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SHEARGUARD CHEST PAD COVERS |
| Generic Name | COVERS |
| Product Code | KME |
| Date Received | 2019-04-12 |
| Model Number | 5844-12 |
| Catalog Number | 5844-12 |
| 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 AVENUE UNION CITY CA 945871234 US 945871234 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-12 |