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 2011-12-07 for DISPOSA-VIEW 8000HDP manufactured by Vital Signs, Inc..
[21975082]
(b)(6), patient information is considered confidential and will not be released by the site. Product evaluated for biological evaluation testing have met the requirements of iso 10993 for a skin contact device. Although standard clinical practice such as periodic checking and re-positioning of the patient during lengthy procedures would likely prevent pressure sores, the instructions for use will be revised to specifically include instructions and warnings related to checking the patient for pressure points.
Patient Sequence No: 1, Text Type: N, H10
[22233589]
The hospital reported that a patient experienced a decutibus ulcer of the second degree which led to partial necrosis during a procedure that involved a head positioner. The intubated patient was positioned in a head prone position due to onset of acute respiratory distress syndrome. After approximately 12 hours in the head prone position in the head positioner, decutibus ulcer was noted at the chin. It was reported that partial necrosis occurred requiring unspecified medical treatment. Reportedly, the site of the ulceration is discolored but is considered healed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2242551-2011-00009 |
| MDR Report Key | 2365813 |
| Report Source | 01,05,06 |
| Date Received | 2011-12-07 |
| Date of Report | 2011-11-07 |
| Date of Event | 2011-10-20 |
| Date Mfgr Received | 2011-11-07 |
| Date Added to Maude | 2011-12-13 |
| 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 | 2011-12-07 |
| Model Number | 8000HDP |
| Lot Number | 20100209 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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. Required No Informationntervention | 2011-12-07 |