MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2017-10-14 for DMEK SURGICAL DISPOSABLE SET 50.2200 manufactured by D.o.r.c International.
[90317160]
This complaint is closed because of the time of occurrence and no actions taken. Since dorc omitted to take timely action to these complaints they will be considered justified. There is a chance of white flakes getting into the eye, while injecting from the pipette therefore reportable. This reportable event was identified during a voluntary retrospective review of all complaints since 2015 by the manufacturer. Details of this activity were discussed with (b)(6) during a tele-conference on (b)(6) 2017. All available information has been provided.
Patient Sequence No: 1, Text Type: N, H10
[90317161]
An event was reported from the (b)(6). There was a mess of the rubber balloon stuck to the pipette. There are white flakes. After rinsing with water, there was another mess. There is no report of a patient injury. No sample was returned for an evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222074-2017-00022 |
| MDR Report Key | 6950564 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2017-10-14 |
| Date of Report | 2014-05-21 |
| Date of Event | 2014-05-21 |
| Date Mfgr Received | 2014-05-21 |
| Date Added to Maude | 2017-10-14 |
| 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 |
| Manufacturer City | EXETER NH 03833 |
| Manufacturer Country | US |
| Manufacturer Postal | 03833 |
| Manufacturer Phone | 6037538824 |
| Manufacturer G1 | D.O.R.C INTERNATIONAL |
| Manufacturer Street | SCHEIJDELVEWEG 2 |
| Manufacturer City | ZUIDLAND, NETHERLANDS 3214VN |
| Manufacturer Country | NL |
| Manufacturer Postal Code | 3214 VN |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DMEK SURGICAL DISPOSABLE SET |
| Generic Name | DMEK SURGICAL DISPOSABLE SET |
| Product Code | MLZ |
| Date Received | 2017-10-14 |
| Catalog Number | 50.2200 |
| Lot Number | 2000361996 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | D.O.R.C INTERNATIONAL |
| Manufacturer Address | SCHEIJDELVEWEG 2 ZUIDLAND, NETHERLANDS 3214VN NL 3214 VN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-14 |