MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-17 for WECK OPHTHALMIC MUSCLE HOOK manufactured by Weck / Teleflex Medical Inc..
[145754918]
During procedure ophthalmic muscle hook snapped and broke in pt's left eye. X-ray performed in operating room suite and showed a metallic foreign body in the orbit. Oculoplastic surgeon/orbital specialist consulted. Since foreign body was surgical stainless steel it was inert in the orbit. Further exploration at this time not recommended. F/u appts with surgeon and specialist scheduled. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086768 |
| MDR Report Key | 8624815 |
| Date Received | 2019-05-17 |
| Date of Report | 2019-05-16 |
| Date of Event | 2019-05-10 |
| Date Added to Maude | 2019-05-20 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | WECK OPHTHALMIC MUSCLE HOOK |
| Generic Name | HOOK, OPTHALMIC |
| Product Code | HNQ |
| Date Received | 2019-05-17 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WECK / TELEFLEX MEDICAL INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-17 |