MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-10-21 for SUTURE GROOVE GOLD WEIGHT manufactured by Iop Inc..
[1307548]
Foreign body reaction to suture groove gold weight implant left upper lid made by iop. Patient had chronic eyelid inflammation. On removing the weight i noticed multiple small pieces of gold in the surrounding capsule. I have had three patients with gold weights made by the same company with chronic inflammation due to the weight. I have never seen a similar reaction with previous weight brands. Dates of use: four months. 2009. Diagnosis or reason for use: lagopthalmos due to facial palsy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5013151 |
| MDR Report Key | 1515843 |
| Date Received | 2009-10-21 |
| Date of Report | 2009-10-21 |
| Date of Event | 2009-09-25 |
| Date Added to Maude | 2009-11-02 |
| 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 | 3 |
| Health Professional | 3 |
| 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 | SUTURE GROOVE GOLD WEIGHT |
| Generic Name | NONE |
| Product Code | HQT |
| Date Received | 2009-10-21 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IOP INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2009-10-21 |