MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2016-10-04 for CLAS II VEST LGE-INTERN. CV102W manufactured by Depuy Synthes Spine.
[56369286]
Udi: gtin not available. A complaint investigation will be performed. The complaint product is not available for the investigation. A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information. Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[56369287]
Bracing for cervical fracture. Rep was called to the (b)(6) hospital by the num of g2 to look at a patient injured wearing our bremer classic ii vest. The patient had developed a large (grade 3) pressure area under his vest. The wound appeared to be under a join where the metal frame attaches to the plastic part of the vest anteriorly on the lower left side. There was a lining attached to the vest covering this join. The patient was very elderly and thin, and the wound was also over a bony structure, l lower rib anteriorly. The vest was removed and the pressure area is being managed. This case is not being reported by the customer, but (b)(6) employee. All available information has been provided as part of this report; no further information will be forthcoming.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1526439-2016-10739 |
| MDR Report Key | 5996498 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-10-04 |
| Date of Report | 2016-09-09 |
| Date of Event | 2016-09-09 |
| Date Mfgr Received | 2016-09-09 |
| Date Added to Maude | 2016-10-04 |
| 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 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JASON BUSCH |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5088808201 |
| Manufacturer G1 | DEPUY SYNTHES SPINE |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02767 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLAS II VEST LGE-INTERN. |
| Generic Name | ORTHOSIS, CERVICAL |
| Product Code | IQK |
| Date Received | 2016-10-04 |
| Catalog Number | CV102W |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY SYNTHES SPINE |
| Manufacturer Address | 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2016-10-04 |