MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-09-26 for DESCRIBE TRANSPARENT PFD PATCH 5035837 manufactured by Merz North America.
[121850413]
This case was assessed as reportable to the fda as the event, permanent scar, was deemed to meet serious injury criteria. The device history record for describe transparent pfd patch lot 17f097 was reviewed. A lot search was conducted on the reported lot and no similar events were noted. No non-concormances were noted that would have contributed to this event.
Patient Sequence No: 1, Text Type: N, H10
[121850414]
This spontaneous report was received from a registered nurse at a laser center and concerns a female patient who is a technician at the office who was using a laser and the describe patch on (b)(6) 2018. Medical history and concomitant medications not reported. During the procedure, the technician removed her goggles and performed the last laser pass without them. She could not see clearly and noted some type of reflection off of the patch. She was seeing dark spots. The patient presented to an ophthalmologist (also reported as an optometrist) for evaluation. Follow up information was received from the reporter via telephone on (b)(6) 2018: the patient has continued to see a retina specialist. Her symptoms are improving with time. Follow up information was received from the reporter via fax on (b)(6) 2018: the patient's initials and age were provided. Medical history reported as negative. Patient is a fitzpatrick skin type ii. The (b)(6) -year-old patient/laser technician removed her goggles during a tattoo removal procedure to observe a pulse through the describe pfd patch, which was being used with a q switch laser. She felt a "pop" in her eye (side not specified) and, shortly thereafter, developed blurry and foggy vision. The patient had an eye exam (not further specified), which confirmed laser impact to the retina in the foveal region of the eye. Per the reporter, the laser impact would have to be from reflection from the patch surface. At no time was the laser aimed at the eye and no direct impact to the eye occurred. The laser only targeted the tattoo and patch on the patient being treated at the time. Lot number reported as 17f0497. Treatment reported as none. Causality reported as "unsure but highly suspicious of role patch played in injury. " follow up information was received from the reporter via telephone on (b)(6) 2018: medical history negative for abnormal vision or the need for visual aids such as reading glasses. It is unknown if the describe pfd patch was wavy or otherwise changed at the time of use. The patient/laser technician removed her goggles during the procedure to "get a better look" at the procedure site, because she had difficulty seeing it through the patch with the goggles on and performed the last pass. The patient/laser technician felt the impact of the laser. It happened very quickly, like a camera flash (not a spark). She blinked multiple times but could not adjust her vision and was seeing spots. The patient saw an optometrist, then a retinal specialist. During exam, "there was a hemorrhage and there is a little scar". The reporter did not know the exact anatomy/location of these. The scar is permanent. Treatment reported as none. The patient/laser technician continues to have blurry vision and has been wearing reading glasses.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3013840437-2018-00001 |
| MDR Report Key | 7911702 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-09-26 |
| Date of Report | 2018-09-26 |
| Date of Event | 2018-08-07 |
| Date Mfgr Received | 2018-09-20 |
| Device Manufacturer Date | 2017-06-09 |
| Date Added to Maude | 2018-09-26 |
| 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 | 3 |
| Manufacturer Contact | SCOTT SYKES, MD |
| Manufacturer Street | 6501 SIX FORKS ROAD |
| Manufacturer City | RALEIGH NC 27615 |
| Manufacturer Country | US |
| Manufacturer Postal | 27615 |
| Manufacturer Phone | 9195828000 |
| Manufacturer G1 | MERZ NORTH AMERICA, INC. |
| Manufacturer Street | 13900 W. GRANDVIEW PARKWAY |
| Manufacturer City | STURTEVANT WI 53177 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53177 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DESCRIBE TRANSPARENT PFD PATCH |
| Generic Name | TRANSPARENT PATCH FOR USE IN TREATMENT OF TATTOOS |
| Product Code | PKO |
| Date Received | 2018-09-26 |
| Model Number | 5035837 |
| Catalog Number | 5035837 |
| Lot Number | 17F0497 |
| Device Expiration Date | 2019-06-09 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MERZ NORTH AMERICA |
| Manufacturer Address | 13900 W. GRANDVIEW PARKWAY STURTEVANT WI 53177 US 53177 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-26 |