MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1997-01-22 for EYE PACK SYE53BSNAA manufactured by Allegiance-surgical Group.
[19234539]
Lint/debris floating in pack. One pt was returned for removal of filament post-op.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423507-1997-00010 |
| MDR Report Key | 178523 |
| Report Source | 05 |
| Date Received | 1997-01-22 |
| Date of Report | 1997-01-22 |
| Date of Event | 1996-11-05 |
| Date Facility Aware | 1996-11-05 |
| Date Reported to Mfgr | 1997-01-08 |
| Date Mfgr Received | 1997-01-08 |
| Device Manufacturer Date | 1996-10-01 |
| Date Added to Maude | 1998-07-24 |
| 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 | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EYE PACK |
| Generic Name | EYE PACK |
| Product Code | HMP |
| Date Received | 1997-01-22 |
| Model Number | SYE53BSNAA |
| Catalog Number | SYE53BSNAA |
| Lot Number | 604262 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 1 MO |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 173588 |
| Manufacturer | ALLEGIANCE-SURGICAL GROUP |
| Manufacturer Address | 1500 WAUKEGAN RD.-BLDG. K MCGAW PARK IL 60085 US |
| Baseline Brand Name | EYE PACK |
| Baseline Generic Name | EYE PACK |
| Baseline Model No | SYE53BSNAA |
| Baseline Catalog No | SYE53BSNAA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1997-01-22 |