MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-02-09 for TIP TOP TORP PROSTHESIS * 14-0920 manufactured by Ent Division Smith And Nephew, Inc..
[106967]
12 yr old status post tympanomastoidectomy & torp reconstruction. Approx 9 months after torp reconstruction, the prosthesis was noted to be extruding partially through the drum. During follow up surgery on 12/22/97, the prosthesis was found to be broken in two pieces. This prosthesis was removed and replaced with another prosthesis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 154946 |
| MDR Report Key | 154946 |
| Date Received | 1998-02-09 |
| Date of Report | 1997-12-31 |
| Date of Event | 1997-12-22 |
| Date Facility Aware | 1997-12-22 |
| Report Date | 1997-12-31 |
| Date Reported to Mfgr | 1997-12-31 |
| Date Added to Maude | 1998-03-11 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | RISK MANAGER |
| 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 | TIP TOP TORP PROSTHESIS |
| Generic Name | EAR PROSTHESIS |
| Product Code | LBN |
| Date Received | 1998-02-09 |
| Model Number | * |
| Catalog Number | 14-0920 |
| Lot Number | * |
| ID Number | PKG. DATE 09/87 3U46060 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 9 MO |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 150927 |
| Manufacturer | ENT DIVISION SMITH AND NEPHEW, INC. |
| Manufacturer Address | 2925 APPLING ROAD BARTLETT TN 38133 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1998-02-09 |