MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-10-19 for SHILHOUETTE 8 PK REFILL 1851646 manufactured by Matrics.
[12611]
On 8/30/94 the dispenser took two ear impressions of this juvenile pt. During the examination he noticed that the pt had drainage tubes installed into both eardrums. Also noticed was that the boy had narrow cannals. The purpose of the visit was to take impressions for open molds for behind the ear instruments. Hal-hen medium sized otoblocks were installed. The impression material was injected and allowed to cure. When the impression material was removed it was noted that it had leaked around the otoblock and contacted the drainage tubes. The drainage tubes came out with the impressions. Follow-uo visit to ent doctor found both ears had not fully healed. More time is needed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1647147-1994-09001 |
| MDR Report Key | 19485 |
| Date Received | 1994-10-19 |
| Date of Report | 1994-09-09 |
| Date of Event | 1994-08-30 |
| Date Facility Aware | 1994-09-08 |
| Date Reported to FDA | 1994-09-09 |
| Date Reported to Mfgr | 1994-09-09 |
| Date Added to Maude | 1995-02-08 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SHILHOUETTE |
| Generic Name | SILICON IMPRESSION KIT FOR EAR MOLDS |
| Product Code | LDG |
| Date Received | 1994-10-19 |
| Model Number | 8 PK REFILL |
| Catalog Number | 1851646 |
| Lot Number | NA |
| Device Expiration Date | 1995-07-18 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 2 MO |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 19398 |
| Manufacturer | MATRICS |
| Manufacturer Address | 47-23 HIAWATHA AVENUE MINNEAPOLIS MN 55406 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1994-10-19 |