MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2000-09-08 for MICROSPONGE 8065-1000-02 manufactured by Alcon Precision Device - Sinking Spring.
[186875]
A surgeon reported that the sponge is "pointy" and stated that this could puncture the cornea. There was no pt impact/injury associated with this report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523835-2000-00007 |
| MDR Report Key | 295397 |
| Report Source | 05,06 |
| Date Received | 2000-09-08 |
| Date of Report | 2000-08-10 |
| Report Date | 2000-08-10 |
| Date Mfgr Received | 2000-08-10 |
| Date Added to Maude | 2000-09-14 |
| 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 |
| Manufacturer Contact | NED LUCE |
| Manufacturer Street | 6201 SOUTH FREEWAY |
| Manufacturer City | FORTH WORTH TX 761342099 |
| Manufacturer Country | US |
| Manufacturer Postal | 761342099 |
| Manufacturer Phone | 8175686470 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MICROSPONGE |
| Generic Name | SPONGE |
| Product Code | HOZ |
| Date Received | 2000-09-08 |
| Model Number | NA |
| Catalog Number | 8065-1000-02 |
| Lot Number | NI |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 285918 |
| Manufacturer | ALCON PRECISION DEVICE - SINKING SPRING |
| Manufacturer Address | 714 COLUMBIA AVENUE SINKING SPRING PA 19608 US |
| Baseline Brand Name | SPONGE |
| Baseline Generic Name | OPHTHALMIC SPONGE |
| Baseline Model No | NA |
| Baseline Catalog No | 8065100002 |
| Baseline ID | NA |
| Baseline Device Family | SURGICAL SPONGE, OPHTHALMIC |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 24 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K896004 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2000-09-08 |