MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07,08 report with the FDA on 2014-11-19 for IMPLANTABLE MINIATURE TELESCOPE manufactured by .
[17579965]
(b)(4).
Patient Sequence No: 1, Text Type: D, B5
[17703270]
Another device from the same lot (10506) was implanted at a different user facility on (b)(6) 2014 and no adverse events have been reported for this patient. The device history record (dhr) for lot 156 was reviewed and no deviations were found. Special attention was paid to the following processes: incoming inspection of short tube and windows; blowing test first and second welding; leak test results from first and second leak test; sterilization process records. Review of mdr, customer complaints and rma history was carried out and no issues which may be a source of a device problem were found. The device was explanted from the patient on (b)(6) 2014 and visioncare has requested that it be returned to them for investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005347768-2014-00002 |
| MDR Report Key | 4349843 |
| Report Source | 07,08 |
| Date Received | 2014-11-19 |
| Date Mfgr Received | 2014-10-23 |
| Device Manufacturer Date | 2012-04-01 |
| Date Added to Maude | 2014-12-23 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | BORIS ARADOVSKY |
| Manufacturer Street | 21 YEGIA KAPAYIM |
| Manufacturer City | PETAH TIKVA 49130 |
| Manufacturer Country | IS |
| Manufacturer Postal | 49130 |
| Manufacturer Phone | 39284002 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMPLANTABLE MINIATURE TELESCOPE |
| Generic Name | TELESCOPE IMPLANTABLE MINIATURE |
| Product Code | NCJ |
| Date Received | 2014-11-19 |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-11-19 |