MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-03-26 for TONO-PEN E518484 manufactured by .
[1296657]
On march 8, 2010 (b) (4). Technical support received a customer concern from (b) (6) hospital - (b) (6) for a tono-pen. He requested that the tono-pen be checked for accuracy because a pt went blind after being tested and indicated that they suspected that the doctor did not use the tono-pen correctly. An rma # (b) (4) was logged and issues to the customer, with a request to send the unit to the address on the rma, to the attention of (b) (4) technical support at (b) (4). Ongoing investigation of the serial number showed that the unit was never serviced by (b) (4). , built and sold in 2001 by medtronic before the sale of the product line to (b) (4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5015420 |
| MDR Report Key | 1652393 |
| Date Received | 2010-03-26 |
| Date of Report | 2010-03-26 |
| Date Added to Maude | 2010-04-09 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TONO-PEN |
| Generic Name | NONE |
| Product Code | HKY |
| Date Received | 2010-03-26 |
| Catalog Number | E518484 |
| ID Number | K852774 |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-03-26 |