MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07,company represent report with the FDA on 2015-01-30 for VENT TUBE - SHEPARD GROMMETS 1016101 manufactured by Medtronic Xomed Inc..
[5498147]
It was reported that a (b)(6) female patient experienced an allergic reaction in her ear postoperatively, during a follow-up visit following the implantation of a fluoroplastic shepard grommet with tab and 1. 14 inner diameter on (b)(6), 2014. It was also reported that the device currently remains implanted in the patient, and the patient has had no other symptoms or complications associated with this event.
Patient Sequence No: 1, Text Type: D, B5
[12801455]
(b)(4): in response to medtronic? S request for device return, no device was received for evaluation? As the device currently remains implanted in the patient. Method: no testing methods performed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[101831926]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045254-2015-00026 |
| MDR Report Key | 4471398 |
| Report Source | 01,05,06,07,COMPANY REPRESENT |
| Date Received | 2015-01-30 |
| Date of Report | 2015-01-07 |
| Date of Event | 2014-12-11 |
| Date Mfgr Received | 2015-01-07 |
| Device Manufacturer Date | 2014-09-11 |
| Date Added to Maude | 2015-01-30 |
| 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 | JACKLYN HAYMAN |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9042812769 |
| 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 - SHEPARD GROMMETS |
| Generic Name | TUBE, TYMPANOSTOMY |
| Product Code | ETD |
| Date Received | 2015-01-30 |
| Model Number | 1016101 |
| Catalog Number | 1016101 |
| Lot Number | 0208738722 |
| Device Expiration Date | 2018-09-10 |
| 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. Other | 2015-01-30 |