MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,06 report with the FDA on 2014-05-02 for VENT TUBE 1028146 50PK SHEEHY 1.27MM SIL manufactured by Medtronic Xomed Inc..
[20714481]
The following information was received via letter notification from fda regarding mdr report #(b)(4) submitted by the user facility: "physician complaint of early extrusion of sheehy 1. 27 mm ear ventilation tube on several patients (8). These early extrusions occur red as early as few months after placement (per physician they should stay in 12-18 months). Date placement of initial tubes ranged from (b)(6) 2012 through (b)(6) 2013. These early extrusions required another surgical procedure to replace them for 7 patients so far. Physician can previously recall only one patient in her practice of several year who experienced that prior to these most recent 9 patients. Physician has stopped using these particular tubes until problem is identified, i. E. , different manufacturing process, different site of manufacture (i. E. , foreign country) etc. " information regarding each individual case was not provided; therefore, one mdr report is being submitted.
Patient Sequence No: 1, Text Type: D, B5
[20959716]
Attempts were made to obtain additional information but further information has not been received. This device is used for therapeutic purposes. The following device lots were reported: (b)(4), lot# 0205408106, mfr 09/2011, exp 09/11/2019. (b)(4), lot# 0205608969, mfr 12/2011, exp 12/07/2019. (b)(4), lot# 0205809485, mfr 03/2012, exp 03/28/2020. (b)(4), lot# 0205993180, mfr 06/2012, exp 06/20/2020. (b)(4), lot# 0206082841, mfr 08/2012, exp 08/08/2020, id# 1028146, lot# 0206198619, mfr 09/2012, exp 09/24/2020. (b)(4), lot# 0206776274, mfr 03/2013, exp 03/02/2021. (b)(4), lot# 0206933852, mfr 04/2013, exp 04/18/2021, (b)(4), lot# 0207425339, mfr 09/2013, exp 09/14/2021. (b)(4): no devices were returned for evaluation. Method? No testing methods performed. (b)(4)
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045254-2014-00097 |
| MDR Report Key | 3787437 |
| Report Source | 00,06 |
| Date Received | 2014-05-02 |
| Date of Report | 2014-04-04 |
| Date Mfgr Received | 2014-04-04 |
| Device Manufacturer Date | 2011-07-07 |
| Date Added to Maude | 2014-05-02 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | CHARLOTTE AYALA |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328372 |
| 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 | VENT TUBE 1028146 50PK SHEEHY 1.27MM SIL |
| Generic Name | TUBE, TYMPANOSTOMY |
| Product Code | ETD |
| Date Received | 2014-05-02 |
| Model Number | 1028146 |
| Catalog Number | 1028146 |
| Lot Number | 0205263090 |
| Device Expiration Date | 2019-07-05 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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 | 2014-05-02 |