MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1998-08-11 for SUPERSORB MICRO-EYE SPONGES E0976 manufactured by Bausch & Lomb Surgical.
[121769]
These sponges are degrading and flaking off during use. There have been no pt involved as this is research facility.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1920664-1998-00166 |
| MDR Report Key | 182207 |
| Report Source | 06 |
| Date Received | 1998-08-11 |
| Date of Report | 1998-07-14 |
| Date of Event | 1998-07-14 |
| Date Facility Aware | 1998-07-14 |
| Report Date | 1998-07-14 |
| Date Reported to Mfgr | 1998-07-14 |
| Date Mfgr Received | 1998-07-14 |
| Device Manufacturer Date | 1997-05-01 |
| Date Added to Maude | 1998-08-17 |
| 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 | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUPERSORB MICRO-EYE SPONGES |
| Generic Name | OPHTHALMIC SPONGES |
| Product Code | HOZ |
| Date Received | 1998-08-11 |
| Model Number | NA |
| Catalog Number | E0976 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 177156 |
| Manufacturer | BAUSCH & LOMB SURGICAL |
| Manufacturer Address | 3365 TREE COURT IND. BLVD. ST. LOUIS MO 631226694 US |
| Baseline Brand Name | SUPERSORB MICRO-EYE SPONGES |
| Baseline Generic Name | OPHTHALMIC SPONGES |
| Baseline Model No | NA |
| Baseline Catalog No | E0976 |
| Baseline ID | NA |
| Baseline Device Family | OPHTHALMIC SPONGES |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K800082 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1998-08-11 |