MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-04-19 for SERENOCAM BC 010 NA manufactured by Corinthian Medical Ltd..
[22074484]
Decreased hearing right ear. Right tympanoplasty with repair of necrosis of incus, using serenocem cement. Pt experienced hearing loss right ear. Prednisone 60mg x 2 weeks, then descreasing dose. Hearing test 4/5 decreased hearing with 0% discrimination. Hearing test 4/8 discrimination 40%, repeat 4/11 no improvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 79457-2002-00001 |
| MDR Report Key | 390975 |
| Date Received | 2002-04-19 |
| Date of Report | 2002-04-09 |
| Date of Event | 2002-03-19 |
| Date Facility Aware | 2002-04-09 |
| Report Date | 2002-04-11 |
| Date Reported to FDA | 2002-04-17 |
| Date Reported to Mfgr | 2002-04-11 |
| Date Added to Maude | 2002-05-02 |
| 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 | SERENOCAM |
| Generic Name | OTOLOGIC BONE CEMENT |
| Product Code | NEA |
| Date Received | 2002-04-19 |
| Model Number | BC 010 |
| Catalog Number | NA |
| Lot Number | 020126-7 |
| ID Number | * |
| Device Expiration Date | 2004-02-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 8 MO |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 380021 |
| Manufacturer | CORINTHIAN MEDICAL LTD. |
| Manufacturer Address | STRELLEY HALL,STRELLEY VILLAGE NOTTINGHAM, NOTTINGHAMSHIRE UK NG8 6PE |
| Baseline Brand Name | SERENOCEM |
| Baseline Generic Name | SERENOCEM |
| Baseline Model No | BC 010 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Baseline Device Family | SERENOCEM |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 36 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K003567 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2002-04-19 |