MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2012-11-08 for DISPOSA-VIEW 8000HDP manufactured by Vital Signs, Inc..
[20981670]
The hospital reported that a pt experienced a, "large excoriation on facial skin," during a procedure that involved a head positioner. The excoriation was noted after surgery and the customer noted the skin damage would have required intervention. The customer further indicated that repositioning the pt during the procedure was not possible due to the type of surgery.
Patient Sequence No: 1, Text Type: D, B5
[21308607]
Under european law, pt info is considered confidential and will not be released by the site. Info regarding the lot number is not available at this time. The device manufacture date cannot be determined without lot number info. Product was evaluated in 2005 and 2006 for biocompatibility testing and showed no cytotoxicity or irritation effects. Subsequent biocompatibility testing conducted in march 2011 showed product met the requirements for: cytotoxicity, systemic toxicity, irritation: primary skin irritation, sensitization using buehler method. Although standard clinical practice such as periodic checking and re-positioning of the pt during lengthy procedures would likely prevent pressure sores, the instructions for use were revised in january 2012 to specifically include instructions and warnings related to checking the pt for pressure points.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2242551-2012-00003 |
| MDR Report Key | 2837448 |
| Report Source | 01,05,06 |
| Date Received | 2012-11-08 |
| Date of Report | 2012-10-12 |
| Date of Event | 2012-08-17 |
| Date Mfgr Received | 2012-10-12 |
| Date Added to Maude | 2012-11-20 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | JOY SONSALLA |
| Manufacturer Street | 3000 N GRANDVIEW BLVD W450 |
| Manufacturer City | WAUKESHA WI 53188 |
| Manufacturer Country | US |
| Manufacturer Postal | 53188 |
| Manufacturer Phone | 2625482661 |
| Manufacturer G1 | VITAL SIGNS, INC. |
| Manufacturer City | TOTOWA NJ |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DISPOSA-VIEW |
| Generic Name | HEAD POSITIONERS |
| Product Code | HBM |
| Date Received | 2012-11-08 |
| Model Number | 8000HDP |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VITAL SIGNS, INC. |
| Manufacturer Address | TOTOWA NJ US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-11-08 |