MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2017-11-07 for MCKESSON 159-22 manufactured by Sunmed Llc..
[91261401]
The customer alleges that "the patient got a scratched cornea from the eye protector. " the affected device was not returned, no lot number was provided and no description of the incident. The product is designed to protect a patient's eyes during a procedure and if used properly, no part of the product comes close to the patient's eyes so it is highly unlikely that it could cause an injury.
Patient Sequence No: 1, Text Type: N, H10
[91261402]
The customer alleges that "the patient got a scratched cornea from the eye protector. " no other details were provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1036445-2017-00001 |
| MDR Report Key | 7007411 |
| Report Source | DISTRIBUTOR |
| Date Received | 2017-11-07 |
| Date of Report | 2017-10-13 |
| Date Added to Maude | 2017-11-07 |
| 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. CARRIE FORTUNA |
| Manufacturer Street | 2710 NORTHRIDGE DR. SUITE A |
| Manufacturer City | GRAND RAPIDS MI 49544 |
| Manufacturer Country | US |
| Manufacturer Postal | 49544 |
| Manufacturer Phone | 6162598400 |
| Manufacturer G1 | SUNMED LLC. |
| Manufacturer Street | 2710 NORTHRIDGE DR. SUITE A |
| Manufacturer City | GRAND RAPIDS MI 49544 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 49544 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MCKESSON |
| Generic Name | EYE PROTECTOR |
| Product Code | HOY |
| Date Received | 2017-11-07 |
| Model Number | 159-22 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SUNMED LLC. |
| Manufacturer Address | 2710 NORTHRIDGE DR. SUITE A GRAND RAPIDS MI 49544 US 49544 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-07 |