MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-17 for DISPOSABLE MICROFORCEPS 2286.KD05 manufactured by D. O. R. C. Dutch Ophthalmic Research Center (international) Bv.
[176043755]
Ilm retinal forcep was faulty, sticking. Fda safety report id: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092366 |
| MDR Report Key | 9610870 |
| Date Received | 2020-01-17 |
| Date of Report | 2020-01-15 |
| Date of Event | 2020-01-13 |
| Date Added to Maude | 2020-01-21 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DISPOSABLE MICROFORCEPS |
| Generic Name | FORCEPS, OPHTHALMIC |
| Product Code | HNR |
| Date Received | 2020-01-17 |
| Catalog Number | 2286.KD05 |
| Lot Number | 20000393611 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | D. O. R. C. DUTCH OPHTHALMIC RESEARCH CENTER (INTERNATIONAL) BV |
| Manufacturer Address | NH 03833 US 03833 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-17 |