MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-02-06 for ULTRACELL 40405-8 manufactured by Aspen Surgical Products, Inc..
[3135741]
Customer was finding that the sponges were leaving fragments when wiped on the surface of the cornea. This was happening in the wet expanded form and the dry form. When used on the stromal bed under a lasik, flap particles were left in the interface of several patients. When used on the stromal bed of prk, many fragments were left and could not be removed with irrigation with bss. Several patients have those sponge fragments now incorporated into their regenerated epithelium.
Patient Sequence No: 1, Text Type: D, B5
[10538334]
Method- product was returned and visual inspection confirmed complaint. Results- operational problem. The dye used to cut the pva spears did not cut as intended, resulting in sponge particulate from the device. Conclusions: maintenance deficiency, all dyes were sent out to be sharpened and a pm was put into place.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1836161-2013-00007 |
| MDR Report Key | 2960416 |
| Report Source | 05 |
| Date Received | 2013-02-06 |
| Date of Report | 2013-02-05 |
| Date of Event | 2010-07-14 |
| Date Mfgr Received | 2010-07-14 |
| Date Added to Maude | 2013-02-15 |
| 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 Street | 6945 SOUTHBELT DR. S.E. |
| Manufacturer City | CALEDONIA MI 49316 |
| Manufacturer Country | US |
| Manufacturer Postal | 49316 |
| Manufacturer Phone | 6166987100 |
| Manufacturer G1 | ASPEN SURGICAL PRODUCTS, INC. |
| Manufacturer Street | 6945 SOUTHBELT DR. S.E. |
| Manufacturer City | CALEDONIA MI 49316 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 49316 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTRACELL |
| Generic Name | PVA EYE SPEAR |
| Product Code | HOZ |
| Date Received | 2013-02-06 |
| Catalog Number | 40405-8 |
| Lot Number | 2013-03-03 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASPEN SURGICAL PRODUCTS, INC. |
| Manufacturer Address | 6945 SOUTHBELT DR. S.E. CALEDONIA MI 49316 US 49316 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-02-06 |