MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07,08 report with the FDA on 1997-11-26 for MEROCEL EYESPEARS * 400101 manufactured by Xomed Surgical Products.
[76941]
Distributor reported that surgeon discovered linting (which he likened to thread) left behind by particular lot of eyespear sponges in the interface during intraocular, lasik surgical procedures. It was further reported that this resulted in severe pt discomfort and physician having to operate on his pts a second time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1045254-1997-00004 |
| MDR Report Key | 135086 |
| Report Source | 01,05,06,07,08 |
| Date Received | 1997-11-26 |
| Date of Report | 1997-11-24 |
| Date of Event | 1997-08-28 |
| Date Mfgr Received | 1997-09-22 |
| Device Manufacturer Date | 1997-08-01 |
| Date Added to Maude | 1997-12-02 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEROCEL EYESPEARS |
| Generic Name | OPHTHALMIC SURGICAL SPONGES |
| Product Code | HOZ |
| Date Received | 1997-11-26 |
| Model Number | * |
| Catalog Number | 400101 |
| Lot Number | 55829 |
| ID Number | * |
| Device Expiration Date | 2000-08-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 131988 |
| Manufacturer | XOMED SURGICAL PRODUCTS |
| Manufacturer Address | 6743 SOUTHPOINT DR. NORTH JACKSONVILLE FL 32216 US |
| Baseline Brand Name | MEROCEL SURGICAL EYE SPEARS |
| Baseline Generic Name | EYE SPEAR SPONGE |
| Baseline Model No | NA |
| Baseline Catalog No | 400101 |
| Baseline ID | NA |
| Baseline Device Family | SPONGE EYE SPEARS |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 36 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1997-11-26 |