MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07,company representati report with the FDA on 2015-01-05 for SHEEHY PARTIAL OSSICULAR PROSTHESIS (POP) 1112362 manufactured by Medtronic Xomed Inc..
[5365590]
It was reported that the doctor found the prosthesis disintegrated inside of the patient. The device was explanted. There were no further complications reported.
Patient Sequence No: 1, Text Type: D, B5
[12653884]
Blank fields on this report are the result of information not being provided by initial reporter. This device is used for therapeutic purposes. (b)(4). Method: no testing methods performed. (b)(4)
Patient Sequence No: 1, Text Type: N, H10
[34317705]
Additional information received regarding the event: the patient was having problems with decreased hearing, pain, and drainage, which prompted the doctor to re-check the prosthesis. All fragments from the disintegrated prosthesis were removed. A repeat tympanoplasty was required. The patient is currently improving. Complainant did not file a medwatch. Information obtained from the nurse on jan. 8, 2015.
Patient Sequence No: 1, Text Type: N, H10
[34317706]
Additional information received regarding the event: the patient was having problems with decreased hearing, pain, and drainage, which prompted the doctor to re-check the prosthesis. All fragments from the disintegrated prosthesis were removed. A repeat tympanoplasty was required. The patient is currently improving.
Patient Sequence No: 1, Text Type: D, B5
[101040371]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045254-2015-00003 |
| MDR Report Key | 4382141 |
| Report Source | 05,06,07,COMPANY REPRESENTATI |
| Date Received | 2015-01-05 |
| Date of Report | 2014-12-11 |
| Date of Event | 2014-11-20 |
| Date Mfgr Received | 2015-01-08 |
| Device Manufacturer Date | 2013-01-23 |
| Date Added to Maude | 2015-01-05 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | AMY CORRALES |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328138 |
| Manufacturer G1 | MEDTRONIC XOMED, INC |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32216 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SHEEHY PARTIAL OSSICULAR PROSTHESIS (POP) |
| Generic Name | REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL |
| Product Code | ETA |
| Date Received | 2015-01-05 |
| Model Number | 1112362 |
| Catalog Number | 1112362 |
| Lot Number | 0206592612 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC XOMED INC. |
| Manufacturer Address | 6743 SOUTHPOINT DR N JACKSONVILLE FL 32216 US 32216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-01-05 |