MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-05-15 for DISPOSABLE ONE STEP SINGLE CANNULA INCLUDING INSERTER. (25 GAUGE / 0.5 MM) 1272.EDPT5 manufactured by Dutch Opthalmic Research Center Bv.
[108727902]
The investigation showed that the lime stone effect happened due to the cyanoacrylate glue. This is discussed with the production department and the procedure has been changed. Cannula seems to have trace of " limestone" hence concluded as reportable. The associated risk is foreign body reaction. (b)(4). All available information has been disclosed. This complaint has now been closed.
Patient Sequence No: 1, Text Type: N, H10
[108727903]
We received a complaint it seems to have trace of " limestone" on it. Sample available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222074-2018-00132 |
| MDR Report Key | 7516740 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-05-15 |
| Date of Report | 2015-10-13 |
| Date of Event | 2015-10-13 |
| Date Mfgr Received | 2015-10-13 |
| Date Added to Maude | 2018-05-15 |
| 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 | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| 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 | 3 |
| Brand Name | DISPOSABLE ONE STEP SINGLE CANNULA INCLUDING INSERTER. (25 GAUGE / 0.5 MM) |
| Generic Name | DISPOSABLE ONE STEP SINGLE CANNULA INCLUDING INSERTER. (25 GAUGE / 0.5 MM) |
| Product Code | NGY |
| Date Received | 2018-05-15 |
| Catalog Number | 1272.EDPT5 |
| Lot Number | 2000368387 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-05-15 |