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 |