MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2006-07-11 for 1937 GENTLE TOUCH PILLOW manufactured by Orthopedic Systems, Inc..
[593225]
Two patients suffered pressure injuries on their chin and inside their mouth. One patient was 7. 5 hrs 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 since returned to normal. The second pt had an ultrasonic renal calculi ablation 4. 25 hours prior and was diabetic. Two days after the procedure her skin reddened. She too has since returned to normal. The concern of the location and the method in which the white soft foam is attached to the blue denser foam. There is a 1cm line of yellow colored glue that attaches the two different materials above the eyes and in the chin area.
Patient Sequence No: 1, Text Type: D, B5
[7868690]
It is unknown how this error happened. Osi distributes thousands of single use pillows each month and this type of problem is rare.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2921578-2006-00002 |
| MDR Report Key | 832035 |
| Report Source | 06 |
| Date Received | 2006-07-11 |
| Date of Report | 2006-07-11 |
| Date of Event | 2006-06-21 |
| Date Mfgr Received | 2006-06-30 |
| Device Manufacturer Date | 2005-10-01 |
| Date Added to Maude | 2007-03-30 |
| 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 | 0 |
| Manufacturer Contact | KIRKE JAYNE |
| Manufacturer Street | 30031 AHERN AVE |
| Manufacturer City | UNION CITY CA 945871234 |
| Manufacturer Country | US |
| Manufacturer Postal | 945871234 |
| Manufacturer Phone | 5104768128 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 1937 GENTLE TOUCH PILLOW |
| Generic Name | PILLOW |
| Product Code | ILZ |
| Date Received | 2006-07-11 |
| Model Number | 1937 |
| Catalog Number | 1937 |
| Lot Number | NA |
| ID Number | 10/26/05 - 11/16/05 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 7 MO |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 718653 |
| Manufacturer | ORTHOPEDIC SYSTEMS, INC. |
| Manufacturer Address | 30031 AHERN AVE. 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 | 1. Required No Informationntervention | 2006-07-11 |