MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-06-21 for GENTLETOUCH 7' HEADREST PILLOW WITH RIGHT INTUBATION SLOT 1937 * manufactured by Orthropedic Systems, Inc..
[474264]
Two patients suffered pressure injuries on their chin and inside their mouth. One patient was 7. 5 hours post-operative after having an ultrasonic renal calculi ablation, and was in good health. Two days after the procedure, his chin became reddened and started leaking serous fluid that became scabbed. He lost sensation on his chin, but has since returned to normal. The second patient had an ultrasonic renal calculi ablation 4. 25 hours prior and was diabetic. Two days after the procedure her skin was reddened. She too has since returned to normal. The concern is the location and the method in which the white soft foam is attached to the blue denser foam. There is a 1 cm line of yellow colored glue that attaches the two different materials above the eyes and in the area below the chin rest. This glue line is hard and rough.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 730365 |
| MDR Report Key | 730365 |
| Date Received | 2006-06-21 |
| Date of Report | 2006-06-21 |
| Report Date | 2006-06-21 |
| Date Reported to FDA | 2006-06-21 |
| Date Added to Maude | 2006-07-03 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GENTLETOUCH 7' HEADREST PILLOW WITH RIGHT INTUBATION SLOT |
| Generic Name | PILLOW, FOAM |
| Product Code | KME |
| Date Received | 2006-06-21 |
| Returned To Mfg | 2006-06-21 |
| Model Number | 1937 |
| Catalog Number | * |
| Lot Number | 10/26/05 AND 11/16/05 |
| ID Number | * |
| Device Availability | R |
| Device Age | 1 DY |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 718653 |
| Manufacturer | ORTHROPEDIC SYSTEMS, INC. |
| Manufacturer Address | 30031 AHERN AVENUE, UNION CITY CA 945871234 US |
| Baseline Brand Name | 1937 GENTLE TOUCH PILLOW |
| Baseline Generic Name | PILLOW |
| Baseline Model No | 1937 |
| Baseline Catalog No | 1937 |
| Baseline ID | 10/26/05 - 11/1 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-06-21 |