MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1997-08-07 for MICROSPONGE 8065100003 manufactured by Alcon Laboratories, Inc..
[17105682]
Surgeon reports sponge gives out a sort of dust and cannot release fragments.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523835-1997-00002 |
| MDR Report Key | 112599 |
| Report Source | 05,06 |
| Date Received | 1997-08-07 |
| Date of Report | 1997-07-09 |
| Date Mfgr Received | 1997-07-09 |
| Device Manufacturer Date | 1997-02-01 |
| Date Added to Maude | 1997-08-14 |
| 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 |
| 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 | SURGICAL SPONGE |
| Product Code | HOZ |
| Date Received | 1997-08-07 |
| Returned To Mfg | 1997-07-09 |
| Model Number | 8065100003 |
| Catalog Number | 8065100003 |
| Lot Number | M001180 |
| ID Number | 510(K) K896004 |
| Device Expiration Date | 2001-12-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 5 MO |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 110536 |
| Manufacturer | ALCON LABORATORIES, INC. |
| Manufacturer Address | 6201 SOUTH FREEWAY FORT WORTH TX 76134 US |
| Baseline Brand Name | SPONGE |
| Baseline Generic Name | OPHTHALMIC SPONGE |
| Baseline Model No | NA |
| Baseline Catalog No | 8065100003 |
| 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 | 1997-08-07 |