MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,07,company representative, report with the FDA on 2014-05-30 for VENT TUBE 1027060 5PK REUTER BOBBIN W/HO manufactured by Medtronic Xomed Inc..
[4680719]
It was reported that there was a possible reaction in the patient from the ear tubes. In (b)(6) of 2013 the patient had the vent tubes placed. A couple of months later she developed eczema, but they did not think much of it because she had had eczema before as a baby (before the vent tubes). Around (b)(6) of 2013, her hair started to fall out; this progressed to complete baldness, including her eye brows and lashes. They went to see a dermatologist who told them it was alopecia. It was noticed that when they would give the patient motrin she would feel better, which made them think it was an inflammation issue. In (b)(6) of this year, the tubes were not working any longer so they had them removed. The next day after removal of the tubes the patient stated her ears did not hurt anymore. A week later the eczema was gone and the patient? S hair is now starting to grow back. The patient was 2 years old at the time of implantation; she is now (b)(6).
Patient Sequence No: 1, Text Type: D, B5
[11801976]
(b)(4): product evaluation: no analysis available; devices not returned for evaluation. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[101035003]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045254-2014-00126 |
| MDR Report Key | 3841268 |
| Report Source | 00,07,COMPANY REPRESENTATIVE, |
| Date Received | 2014-05-30 |
| Date of Report | 2014-05-06 |
| Date Mfgr Received | 2014-05-06 |
| Device Manufacturer Date | 2012-09-24 |
| Date Added to Maude | 2014-05-30 |
| 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 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MICHELLE ALFORD |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328197 |
| 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 1027060 5PK REUTER BOBBIN W/HO |
| Generic Name | TUBE, TYMPANOSTOMY |
| Product Code | ETD |
| Date Received | 2014-05-30 |
| Model Number | 1027060 |
| Catalog Number | 1027060 |
| Lot Number | 0206192722 |
| 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 NORTH JACKSONVILLE FL 32216 US 32216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-05-30 |