MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2016-10-13 for LYN051BSOGA manufactured by Medline Industries Inc.
[57318563]
Blue fibers thought to be from back table cover in cataract pack found in surgical site. Fibers flushed out of site, incision did not have to be enlarged to remove the fibers. No injury or need for further intervention. Sample has not been returned, have not confirmed the issue or identified a root cause. Due to the need for intervention to remove the blue fibers this medwatch is being filed. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[57318564]
Blue fibers thought to be from the back table cover were seen in the surgical site.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423395-2016-00047 |
| MDR Report Key | 6026500 |
| Report Source | DISTRIBUTOR |
| Date Received | 2016-10-13 |
| Date of Report | 2016-10-14 |
| Date of Event | 2016-09-14 |
| Date Mfgr Received | 2016-09-15 |
| Date Added to Maude | 2016-10-13 |
| 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 | JULIE FINLEY |
| Manufacturer Street | ONE MEDLINE PLACE |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal | 60060 |
| Manufacturer Phone | 8476434709 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | BACK TABLE COVER IN CATARACT PACK |
| Product Code | OJK |
| Date Received | 2016-10-13 |
| Catalog Number | LYN051BSOGA |
| Lot Number | 16DB2569 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES INC |
| Manufacturer Address | ONE MEDLINE PLACE MUNDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2016-10-13 |