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 2020-03-19 for 25GA RETRACTABLE DIAMOND DUSTED MEMBRANE SCRAPER 20.16.25 manufactured by Bausch + Lomb.
[186833090]
The device history record evaluation did not reveal any negative quality patterns. There were no nonconformances for this issue reported during the manufacture of this lot. The product was not returned. This was the only complaint received in the last 4 years for this issue. It appears to be an isolated case at this point in time. Ifu recently updated to add step to ensure tip is not exposed during insertion which could damage tip resulting in this failure mode the lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates. No corrective action required.
Patient Sequence No: 1, Text Type: N, H10
[186833091]
The user facility in (b)(6) reported diamond dust fell from the ddms (diamond dusted membrane scraper). The surgeon continued the procedure and aspirated the diamond dust from the retina. No patient issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001920664-2020-00046 |
| MDR Report Key | 9856550 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-19 |
| Date of Report | 2020-02-26 |
| Date of Event | 2020-02-25 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-02-26 |
| Date Added to Maude | 2020-03-19 |
| 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. JULI MOORE |
| Manufacturer Street | 3365 TREE COURT INDUSTRIAL BLV |
| Manufacturer City | ST. LOUIS MO 63122 |
| Manufacturer Country | US |
| Manufacturer Postal | 63122 |
| Manufacturer Phone | 6362263220 |
| Manufacturer G1 | SYNERGETICS |
| Manufacturer Street | 3345 CORPORATE CENTRE DR |
| Manufacturer City | O''FALLON MO 63368 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 63368 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 25GA RETRACTABLE DIAMOND DUSTED MEMBRANE SCRAPER |
| Generic Name | HAND HELD INSTRUMENT |
| Product Code | MDM |
| Date Received | 2020-03-19 |
| Model Number | 20.16.25 |
| Catalog Number | 20.16.25 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAUSCH + LOMB |
| Manufacturer Address | ROCHESTER NY 14609 US 14609 |
| Product Code | --- |
| Date Received | 2020-03-19 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-19 |