MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-04 for MICRO BOBBIN VT 1.27 MM TI 145781 manufactured by Gyrus Acmi, Inc..
| Report Number | 1037007-2015-00005 |
| MDR Report Key | 5056873 |
| Date Received | 2015-09-04 |
| Date of Report | 2015-08-06 |
| Date of Event | 2015-07-07 |
| Date Mfgr Received | 2015-08-06 |
| Device Manufacturer Date | 2014-08-05 |
| Date Added to Maude | 2015-09-04 |
| 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 | MS ANGELA CAPUTO |
| Manufacturer Street | 136 TURNPIKE RD |
| Manufacturer City | SOUTHBOROUGH MA 01772 |
| Manufacturer Country | US |
| Manufacturer Postal | 01772 |
| Manufacturer Phone | 5088042667 |
| Manufacturer G1 | GYRUS ACMI, INC. |
| Manufacturer Street | 2925 APPLING RD |
| Manufacturer City | BARTLETT TN 38133 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38133 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MICRO BOBBIN VT 1.27 MM TI |
| Generic Name | MICRO BOBBIN |
| Product Code | ETD |
| Date Received | 2015-09-04 |
| Returned To Mfg | 2015-08-27 |
| Model Number | 145781 |
| Lot Number | IH892762 |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GYRUS ACMI, INC. |
| Manufacturer Address | 2925 APPLING RD BARTLETT TN 38133 US 38133 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-09-04 |