MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-06-24 for HERRICK LACRIMAL PLUG 3 MM manufactured by Lacrimedics, Inc..
[17512958]
Pt had treatment for dry eyes on 4/6/94, with mfrs plugs. On 5/27/94, after 7 weeks of normal function, pt developed right dacryocystitis with alpha strep and gram (-) rods requiring dacryocystotomy and drainage of preseptal abscess and iv antibiotics for 7 days. The package insert indicates the plugs are labelled with a radiopaque agent, however the co told rptr that this has never been done. Plug could not be visualized on x-ray as claimed in package insert. (*)
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1002575 |
| MDR Report Key | 14321 |
| Date Received | 1994-06-24 |
| Date of Report | 1994-06-08 |
| Date of Event | 1994-05-27 |
| Date Added to Maude | 1994-06-27 |
| 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 |
| 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 | HERRICK LACRIMAL PLUG |
| Generic Name | SILICONE PLUG |
| Product Code | HNL |
| Date Received | 1994-06-24 |
| Model Number | 3 MM |
| Device Availability | N |
| Implant Flag | Y |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 14317 |
| Manufacturer | LACRIMEDICS, INC. |
| Manufacturer Address | RIALTO CA 92376 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 1994-06-24 |