MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 1997-12-19 for MICROSPONGE 8065100003 manufactured by Alcon Laboratories.
[73355]
Surgeon reports sponge leaves pieces or threads in the pt's eye. No injury was experienced however the surgeon reports that if this event were to recur it could cause or contribute to pt injury.
Patient Sequence No: 1, Text Type: D, B5
[21821139]
H. 6: the returned samples appear to have been used in surgery and exhibited some loose white particles from the sponge material. There have been no other complaints on this lot which was mfg before material improvements by the supplier and improved cutting process by alcon mfg. This report was mailed in to fda on: 5/1/1998.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523835-1997-00004 |
| MDR Report Key | 140553 |
| Report Source | 01,05,06 |
| Date Received | 1997-12-19 |
| Date of Report | 1997-11-21 |
| Date Mfgr Received | 1997-11-21 |
| Device Manufacturer Date | 1997-04-01 |
| Date Added to Maude | 1997-12-31 |
| 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 | 1997-12-19 |
| Returned To Mfg | 1997-11-21 |
| Model Number | 8065100003 |
| Catalog Number | 8065100003 |
| Lot Number | M038890 |
| ID Number | NA |
| Device Expiration Date | 2002-02-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | NO INFO |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 137215 |
| Manufacturer | ALCON LABORATORIES |
| Manufacturer Address | 714 COLUMBIA AVE. SINKING SPRING PA 19608 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 | 1997-12-19 |