MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-11-09 for WEIL BLAKESLY THRU CUT 230728 manufactured by Gyrus Medical Gmbh.
[21019232]
Instrument broke inside the pt. Reporter believes that all pieces were retrieved.
Patient Sequence No: 1, Text Type: D, B5
[21307709]
Evaluated by gyrus medical (b)(4), damaged by normal wear and tear.
Patient Sequence No: 1, Text Type: N, H10
Report Number | 1037007-2012-00006 |
MDR Report Key | 2834798 |
Report Source | 06 |
Date Received | 2012-11-09 |
Date of Report | 2012-08-15 |
Date of Event | 2012-08-15 |
Date Mfgr Received | 2012-08-15 |
Date Added to Maude | 2013-02-15 |
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 | 0 |
Health Professional | 0 |
Initial Report to FDA | 3 |
Report to FDA | 0 |
Event Location | 0 |
Manufacturer Contact | DOLAN MILLS |
Manufacturer Street | 2925 APPLING RD |
Manufacturer City | BARTLETT TN 38133 |
Manufacturer Country | US |
Manufacturer Postal | 38133 |
Manufacturer Phone | 9013730200 |
Manufacturer G1 | GYRUS MEDICAL GMBH |
Manufacturer Street | GOTENSTR 3 |
Manufacturer City | BUTTLINGEN D-78532 |
Manufacturer Country | GM |
Manufacturer Postal Code | D-78532 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | WEIL BLAKESLY THRU CUT |
Product Code | KAE |
Date Received | 2012-11-09 |
Returned To Mfg | 2012-09-06 |
Catalog Number | 230728 |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Device Age | DA |
Device Eval'ed by Mfgr | Y |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | GYRUS MEDICAL GMBH |
Manufacturer Address | TUTTLINGEN GM |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Required No Informationntervention | 2012-11-09 |