MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1997-08-22 for JOHNSON & JOHNSON EYE PADS 8771 manufactured by Johnson & Johnson Medical, Inc..
[68445]
Caller states that pc8771 was used to cover the eye of a 28 year old female. Six hours later she complained of a raised red itching reaction. Pt did not return to the dr for a followup until 8/18/97. The dr has found "superficial scarring under her eye. " the current pt condition was called in on 8/19/97.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1618732-1997-00182 |
| MDR Report Key | 114732 |
| Report Source | 05 |
| Date Received | 1997-08-22 |
| Date of Report | 1997-08-19 |
| Date of Event | 1997-07-01 |
| Date Facility Aware | 1997-07-07 |
| Report Date | 1997-08-19 |
| Date Mfgr Received | 1997-07-07 |
| Device Manufacturer Date | 1995-08-01 |
| Date Added to Maude | 1997-08-25 |
| 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 | JOHNSON & JOHNSON EYE PADS |
| Generic Name | PADS, EYE |
| Product Code | HMP |
| Date Received | 1997-08-22 |
| Model Number | NA |
| Catalog Number | 8771 |
| Lot Number | AUG;53161 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 112627 |
| Manufacturer | JOHNSON & JOHNSON MEDICAL, INC. |
| Manufacturer Address | 2500 ARBROOK BLVD. ARLINGTON TX 760143899 US |
| Baseline Brand Name | JOHNSON & JOHNSON EYE PADS |
| Baseline Generic Name | PAD, EYE |
| Baseline Model No | * |
| Baseline Catalog No | 8771 |
| Baseline ID | * |
| Baseline Device Family | EYE PAD |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 60 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-08-22 |