MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2013-08-06 for 0.4MM DIA 4.25MM LG, PL/FP 141815 manufactured by Gyrus Acmi, Inc.
[3645206]
It was reported that during a mri procedure the pt complained of pain at the site of the implant and a headache in the forehead area during the mri. Once removed from the machine the pain subsided within 10 minutes.
Patient Sequence No: 1, Text Type: D, B5
[10918128]
At the time of this report, the device has not yet been returned for eval. As a result, a determination cannot be made at this time. If further info becomes available, gyrus acmi will continue the investigation and update the agency accordingly.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1037007-2013-00013 |
| MDR Report Key | 3327082 |
| Report Source | 06,07 |
| Date Received | 2013-08-06 |
| Date of Report | 2013-07-16 |
| Date Mfgr Received | 2013-07-16 |
| Device Manufacturer Date | 2011-04-01 |
| Date Added to Maude | 2013-09-12 |
| 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 | TERRENCE SULLIVAN |
| Manufacturer Street | 136 TURNPIKE RD |
| Manufacturer City | SOUTHBOROUGH MA 01772 |
| Manufacturer Country | US |
| Manufacturer Postal | 01772 |
| Manufacturer Phone | 5088042739 |
| Manufacturer G1 | GYRUS ACMI, INC |
| Manufacturer Street | 2925 APPLING RD. |
| Manufacturer City | BARTLETT TN 38133390 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38133 3901 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 0.4MM DIA 4.25MM LG, PL/FP |
| Generic Name | 0.4MM DIA 4.25MM LG, PL/FP |
| Product Code | ETB |
| Date Received | 2013-08-06 |
| Model Number | 141815 |
| Catalog Number | 141815 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GYRUS ACMI, INC |
| Manufacturer Address | BARTLETT TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-08-06 |