MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-09-25 for SOFT CELL PVA FOAM SURGICAL SPEAR 0525 manufactured by Oasis Medical, Inc..
[717141]
Surgery date 2007. Trace dlk noted day 1 right eye. Pred forte increased to every 2 hrs. Dlk resolved and on last follow up 2 days later, vision was 20/20 ou without correction.
Patient Sequence No: 1, Text Type: D, B5
[7865063]
Upon notification a review of production records was initiated. There were no anomalies or remarkable events that occurred that would adversely impact the product. Of the spears distributed to date, there have been no other adverse events or complaints reported regarding product #0525, lot # 163282. At this time, there is no evidence to suggest that the soft cell pva foam surgical spears product #0525, lot #163282 are directly or indirectly responsible for the reported dlk observation.
Patient Sequence No: 1, Text Type: N, H10
[6076659]
Surgery date 2007. Trace dlk noted od on pod 1. Pred forte increased to every 2 hrs. Last follow up one week later. A few cells remained. Pt refracted to 20/20 with mild myopic correction.
Patient Sequence No: 2, Text Type: D, B5
[14310346]
Upon notification a review of production records was initiated. There were no anomalies or remarkable events that occurred that would adversely impact the product. Of the spears distributed to date, there have been no other adverse events or complaints reported regarding product #0525, lot # 163282. At this time there is no evidence to suggest that the soft cell pva foam surgical spears product #0525, lot #163282 are directly or indirectly responsible for the reported dlk observation.
Patient Sequence No: 2, Text Type: N, H10
[6344797]
Surgery 2007. Trace dlk os on pod #1... Pred forte every 2 hrs. Did not progress but still present on day 4 (4 days later). Vision 20/25 without correction.
Patient Sequence No: 3, Text Type: D, B5
[14088671]
Upon notification a review of production records was initiated. There were no anomalies or remarkable events that occurred that would adversely impact the product. Of the spears distributed to date, there have been no other adverse events or complaints reported regarding product #0525, lot # 163282. At this time there is no evidence to suggest that the soft cell pva foam surgical spears product #0525, lot #163282 are directly or indirectly responsible for the reported dlk observation.
Patient Sequence No: 3, Text Type: N, H10
[6320011]
Surgery 2007. Trace dlk od with small fiber assoicated with the dlk. Pred forte every 2 hrs. Day 3 vision 20/20... Dlk resolved (3 days later).
Patient Sequence No: 4, Text Type: D, B5
[14236005]
Upon notification a review of production records was initiated. There were no anomalies or remarkable events that occurred that would adversely impact the product. Of the spears distributed to date, there have been no other adverse events or complaints reported regarding product #0525, lot # 163282. At this time there is no evidence to suggest that the soft cell pva foam surgical spears product #0525, lot #163282 are directly or indirectly responsible for the reported dlk observation.
Patient Sequence No: 4, Text Type: N, H10
[6082307]
Surgery 2007 at day 1, stage 1 dlk noted in both eyes. Pred forte every hour while awake prescribed. On day 3, dlk progressed to stage 2 in front of pupil but was not dense. Saw pt again on day 4 (4 days later), dlk was no worse, vision 20/20 uncorrected. Cells very sparse. Will follow.
Patient Sequence No: 5, Text Type: D, B5
[14140536]
Upon notification a review of production records was initiated. There were no anomalies or remarkable events that occurred that would adversely impact the product. Of the spears distributed to date, there have been no other adverse events or complaints reported regarding product #0525, lot # 163282. At this time there is no evidence to suggest that the soft cell pva foam surgical spears product #0525, lot #163282 are directly or indirectly responsible for the reported dlk observation.
Patient Sequence No: 5, Text Type: N, H10
| Report Number | 2083373-2007-00005 |
| MDR Report Key | 921733 |
| Report Source | 05 |
| Date Received | 2007-09-25 |
| Date of Report | 2007-09-25 |
| Date Mfgr Received | 2007-09-12 |
| Device Manufacturer Date | 2007-07-01 |
| Date Added to Maude | 2007-11-20 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ROBYN SCOPIS, MANAGER |
| Manufacturer Street | 514 SOUTH VERMONT AVE. |
| Manufacturer City | GLENDORA CA 91741 |
| Manufacturer Country | US |
| Manufacturer Postal | 91741 |
| Manufacturer Phone | 6268525156 |
| Single Use | 3 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SOFT CELL PVA FOAM SURGICAL SPEAR |
| Generic Name | FOAM SPEAR |
| Product Code | HOZ |
| Date Received | 2007-09-25 |
| Model Number | 0525 |
| Lot Number | 163282 |
| Device Expiration Date | 2010-07-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 898250 |
| Manufacturer | OASIS MEDICAL, INC. |
| Manufacturer Address | 514 S VERMONT AVE GLENDALE CA 92741 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-09-25 |
| 2 | 0 | 2007-09-25 | |
| 3 | 0 | 2007-09-25 | |
| 4 | 0 | 2007-09-25 | |
| 5 | 0 | 2007-09-25 |