MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-07-22 for OCUSERT PILO-40 UNK manufactured by Alza Corp..
[18484363]
Pt has been using ocusert for 20 yrs and noticed the difference when using new ones. Pt went to see her opthalmalogist and it was noted that the rim is not as heavy and they twist together. They get stuck in pts eyes twisted. Pt contacted mfr and was told mfr sold to another co and that no changes have been made in the ocusert.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1014208 |
| MDR Report Key | 178335 |
| Date Received | 1998-07-22 |
| Date of Report | 1998-07-22 |
| Date of Event | 1998-05-01 |
| Date Added to Maude | 1998-07-24 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OCUSERT PILO-40 |
| Generic Name | UNK |
| Product Code | MRH |
| Date Received | 1998-07-22 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | 179249 |
| ID Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 173403 |
| Manufacturer | ALZA CORP. |
| Manufacturer Address | 950 PAGE MILL RD. PALO ALTO CA 943030802 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-07-22 |