MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2008-12-05 for CAUSSE LARGE LOOP PISTON 1156241 manufactured by Medtronic Xomed, Inc..
[20995537]
A medtronic employee was notified of an incident by a pharmacist from hospital. The doctor states that he had to revise a case of otosclerosis because the fluoroplastic loop material of the piston implant, which should have shape memory, opened up again. Surgeon states that this is the first of two cases this week with the same lot number. The facility indicated that there was no patient injury. Note: this mdr is for case 1 of 2. Case two is reported in a separate mdr.
Patient Sequence No: 1, Text Type: D, B5
[21224398]
Multiple attempts to obtain additional information from the customer were not successful. The product was unavailable for return; therefore, an evaluation of the performance of the reported device was not possible. There is no inventory remaining of the reported lot number. The device history records were reviewed. No issues, no anomalies found on this product and lot. A similar piston was evaluated and material met the product specification. Reference mdr# 1045254-2008-00041.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045254-2008-00040 |
| MDR Report Key | 1290902 |
| Report Source | 05,07 |
| Date Received | 2008-12-05 |
| Date of Report | 2008-12-05 |
| Date of Event | 2008-10-24 |
| Date Reported to Mfgr | 2008-11-07 |
| Date Mfgr Received | 2008-11-07 |
| Device Manufacturer Date | 2008-02-15 |
| Date Added to Maude | 2009-07-24 |
| 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 |
| Reporter Occupation | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | MIKE MOSBY |
| Manufacturer Street | 6743 SOUTHPOINT DR. NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9042797584 |
| Manufacturer G1 | MEDTRONIC XOMED, INC. |
| Manufacturer Street | 6743 SOUTHPOINT DR. 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 | CAUSSE LARGE LOOP PISTON |
| Generic Name | PROSTHESIS, EAR, INTERNAL |
| Product Code | FZD |
| Date Received | 2008-12-05 |
| Model Number | 1156241 |
| Catalog Number | 1156241 |
| Lot Number | 54501600 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 9 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC XOMED, INC. |
| Manufacturer Address | JACKSONVILLE FL 32216 US 32216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-12-05 |