MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-06-13 for VERSAPACK 20027S manufactured by Synergetics.
[4001949]
As reported to our sales rep from a facility staff member, the surgeon had completed a 27ga case and everything seemed fine. The wounds sealed and pt was sent to post-op. After being in post-op for about 15 mins, surgeon was called out to look at the pt. The pt's eye was leaking from all three wounds and sterile air had to be injected. The pt suffered a choroidal hemorrhage as a result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1932402-2013-00006 |
| MDR Report Key | 3481130 |
| Report Source | 07 |
| Date Received | 2013-06-13 |
| Date of Report | 2013-06-14 |
| Date of Event | 2013-06-04 |
| Date Mfgr Received | 2013-06-04 |
| Date Added to Maude | 2013-11-22 |
| 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 | DAN REGAN |
| Manufacturer Street | 3845 CORPORATE CENTRE DR. |
| Manufacturer City | O'FALLON MO 63368 |
| Manufacturer Country | US |
| Manufacturer Postal | 63368 |
| Manufacturer Phone | 6367945013 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VERSAPACK |
| Generic Name | VITRECTOMY CONVEINENCE PACK |
| Product Code | MLZ |
| Date Received | 2013-06-13 |
| Model Number | 20027S |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNERGETICS |
| Manufacturer Address | 3845 CORPORATE CENTRE DR. O'FALLON MO 63368 US 63368 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-06-13 |