MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2015-12-07 for COX II 21-264HLE, 21-264HRE manufactured by Oculo-plastik, Inc..
[32792886]
We misinterpreted the explanation in the mdr determination sheet as follows however, we now understand that because there was medical intervention the incident is reportable even if there was no permanent impairment or damage. C) did the event necessitate medical or surgical intervention by a health care professional to preclude permanent impairment a body function or permanent damage to a body structure? (circular abrasion did not cause permanent impairment or permanent damage). We have informed (b)(6) by email and (b)(6) by voice mail that we are closing this report, sept 10, 2015. Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[32792888]
We received email from (b)(6) on behalf of (b)(6). (b)(6) claims that one of their customers ((b)(6)) has reported that a patient had circular abrasions on both eyes post fraxel treatment with oculo plastik metal eye shields with handle. We contacted (b)(6) on july 28, 2015 and (b)(4) spoke with her directly. (b)(6) (aesthetician) said that it was the first time she was using the eye shields. The eyeshields were purchased back in 2012. (b)(6) said that she inspected the eyeshields and they seemed to be fine. She feels that the patient had very dry eyes and that is the reason that the abrasions occurred. I requested that she send the eye shields back to us for evaluation. I asked for her email, so that i can send there the report after evaluation but she did not want to give it to me and said that it is preferable to contact her by phone. The instructions for use indicate that the ocular shield should be "refurbished" once per year which is re-polishing of polished area that is inserted facing the eye and retreated on exterior side facing the laser to avoid reflection of laser light. "even though these devices are low maintenance, they must be handled with extreme car in order to maintain their quality and safety performances. To ensure protection of the patient and the o. R. Personnel a yearly refurbishing is suggested, although the condition of the shield or instrument will give a better indication. " it is also indicated the eye shield should be inspection for scratches visually. The eye shields in question were purchased in 2012. We do not have any records that the eyeshields were sent back to us for refurbishing. We have been waiting to receive the eye shields. Last attempt of contact with (b)(6) was september 15, 2015. We were not aware that we have to report the incident since(b)(6) (user) did not mention that the eye shields caused permanent damage. (b)(6) also mentioned during telephone conversation that the cause of the cirecular abrasion was related to the patient's dry eyes and not to the shields. We were however, informed by fda inspector that this incident is reportable anyway. We are waiting for a response from (b)(6). I called september 15, 2015 to se why i have not received the shields as yet and i left a message for (b)(6) to call me back. 2015-09-15. I also emailed (b)(6) for further information concerning this event on 2015-09-15 from whom i initially received the report concerning circular abrasion.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8022166-2015-00002 |
| MDR Report Key | 5270790 |
| Report Source | DISTRIBUTOR |
| Date Received | 2015-12-07 |
| Date of Report | 2015-09-15 |
| Date of Event | 2015-05-21 |
| Date Mfgr Received | 2015-07-27 |
| Device Manufacturer Date | 2012-01-03 |
| Date Added to Maude | 2015-12-07 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS VICKY IKONOMOU |
| Manufacturer Street | 200, SAUV |
| Manufacturer City | MONTREAL, QUEBEC H3L1Y9 |
| Manufacturer Country | CA |
| Manufacturer Postal | H3L1Y9 |
| Manufacturer Phone | 3813292 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COX II |
| Generic Name | STAINLESS STEEL OCULAR LASER SHIELD |
| Product Code | HOY |
| Date Received | 2015-12-07 |
| Model Number | 21-264HLE, 21-264HRE |
| Catalog Number | 21-264HLE, 21-264HRE |
| Lot Number | 15294, 15374 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OCULO-PLASTIK, INC. |
| Manufacturer Address | 200, SAUV? OUEST MONTREAL, QUEBEC H3L 1Y9 CA H3L 1Y9 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-12-07 |