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 2015-01-06 for ARMSTRONG BEVELED GROMMETS 1066032 manufactured by Medtronic Xomed Inc..
[5305873]
It was reported that a patient experienced a skin rash postoperatively; following the implantation of an armstrong beveled grommet on (b)(6) 2014. It was also reported that the device currently remains implanted in the patient.
Patient Sequence No: 1, Text Type: D, B5
[12745005]
(b)(4): in response to medtronic? S request for device return, no device was received for evaluation. Method: no testing methods performed. (b)(4). This device is used for therapeutic purposes.
Patient Sequence No: 1, Text Type: N, H10
[23725160]
The following additional information was received on january 06, 2015... Device lot #0208513932. Date of manufacture: july 07, 2014. Expiration date: july 07, 2022. The following additional information was received on january 07, 2015... Product will not be returned for evaluation... At the physician's discretion, it will remain implanted in the patient. "the patient had the same/similar device implanted in a previous surgery without any allergic reactions reported. " "the skin rash/redness was noted on patient's upper chest and face upon arrival in post-anesthesia care unit. The patient was given antihistamine (diphenhydramine) and the rash resolved. There were no adverse reactions reported the next day. " patient status: the following additional information was received january 19, 2015... "regarding the patient's status to date... According to dr. (b)(6), the attending surgeon for the patient concerned in this case, the patient has no reported concerns or complications. "
Patient Sequence No: 1, Text Type: N, H10
[23725161]
Patient Sequence No: 1, Text Type: D, B5
[101049127]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[101831553]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045254-2015-00006 |
| MDR Report Key | 4388053 |
| Report Source | 01,05,06,07,COMPANY REPRESENT |
| Date Received | 2015-01-06 |
| Date of Report | 2014-12-12 |
| Date of Event | 2014-12-12 |
| Date Mfgr Received | 2015-01-06 |
| Device Manufacturer Date | 2014-07-07 |
| Date Added to Maude | 2015-01-06 |
| 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 | ARMSTRONG BEVELED GROMMETS |
| Generic Name | TUBE, TYMPANOSTOMY |
| Product Code | ETD |
| Date Received | 2015-01-06 |
| Model Number | 1066032 |
| Catalog Number | 1066032 |
| Lot Number | 0208513932 |
| 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 | 2015-01-06 |