MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-02 for DISPOSABLE ECKARDT TWINLIGHT CHANDELIER. (27 GAUGE / 0.4MM) 3269.MBD27 manufactured by Dutch Opthalmic Research Center Bv.
[107473144]
Investigation could not reveal the root cause, due to severe contamination. Since it is containing silicon dirt, foreign particles, can cause foreign body reaction to patient, hence it is concluded as reportable. This reportable event was identified during a voluntary retrospective review of all complaints since 2015 by the manufacturer (b)(4) details of this activity were discussed with cdrh office of compliance (b)(4) ) during a tele-conference on (b)(4) 2017. All available information has been provided. This complaint has now been closed.
Patient Sequence No: 1, Text Type: N, H10
[107473145]
A report has been received of an event that occurred in (b)(6): there have been two particles which are probably from the silicon medical grade. It`s difficult to recognize at the photos but we could definitely see them. She tried to save them but they have been too thin so we lost them.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222074-2018-00092 |
| MDR Report Key | 7480345 |
| Date Received | 2018-05-02 |
| Date of Report | 2015-04-28 |
| Date of Event | 2015-04-28 |
| Date Mfgr Received | 2018-04-28 |
| Date Added to Maude | 2018-05-02 |
| 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 | MS LAURA SMITH |
| Manufacturer Street | 10 CONTINENTAL DR BLDG 1 |
| Manufacturer City | EXETER NH 03833 |
| Manufacturer Country | US |
| Manufacturer Postal | 03833 |
| Manufacturer Phone | 6037786929 |
| Manufacturer G1 | DUTCH OPTHALMIC RESEARCH CENTER BV |
| Manufacturer Street | SCHEIJDELVEWEG 2 |
| Manufacturer City | ZUIDLAND, 3214VN |
| Manufacturer Country | NL |
| Manufacturer Postal Code | 3214VN |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DISPOSABLE ECKARDT TWINLIGHT CHANDELIER. (27 GAUGE / 0.4MM) |
| Generic Name | DISPOSABLE ECKARDT TWINLIGHT CHANDELIER. (27 GAUGE / 0.4MM) |
| Product Code | MPA |
| Date Received | 2018-05-02 |
| Catalog Number | 3269.MBD27 |
| Lot Number | 2000368813 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DUTCH OPTHALMIC RESEARCH CENTER BV |
| Manufacturer Address | SCHEIJDELVEWEG 2 ZUIDLAND, 3214VN NL 3214VN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-02 |