MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-10-01 for DYA-PULSE -DYNAPULSE--NOT SURE- * manufactured by Unk.
[20512984]
Following eye surgery for eye lid lift, my chiropractor suggested using his machine, dynapulse, to help my incisions heal faster. I had three or four sessions with him where he targeted the machine on my eyes. The plastic surgeon commented that he had not seen anyone heal quite so fast; however, following the treatments i have increased problems with dry eyes. The chiropractor had showed me photos of a different woman who had similar surgery and had used the machine. Her eyes looked red and he said he had helped her. I did not get her name and he told me that she has since passed away--so i don't know what her outcome was. He told me the machine would not be as hot as diathermy, but the machine was placed close to my eyes. Another chiropractor in with him had cut himself and had stitches. He used the dynapulse on his cut and was able to remove the stitches the next day.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1036794 |
| MDR Report Key | 746939 |
| Date Received | 2005-10-01 |
| Date of Report | 2005-10-01 |
| Date of Event | 2004-10-10 |
| Date Added to Maude | 2006-08-15 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| 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 | DYA-PULSE -DYNAPULSE--NOT SURE- |
| Generic Name | UNSURE |
| Product Code | LXF |
| Date Received | 2005-10-01 |
| Model Number | NA |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 734728 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-10-01 |