• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK LLC US UNKNOWN FMS PRODUCT

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DEPUY MITEK LLC US UNKNOWN FMS PRODUCT Back to Search Results
Catalog Number UNK FMS PRODUCT
Device Problem Connection Problem (2900)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/11/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Udi: unavailable. Depuy synthes has been informed that the catalog number and lot number are not available.  .
 
Event Description
The blade of the shaver did not fit on the handpiece. Product information: code and lot: unk.
 
Manufacturer Narrative
(b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. The complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation. This complaint cannot be confirmed. Further, no lot numbers were supplied which precludes conducting a device history record (dhr) review or a lot specific search in the complaints handling system. No further information regarding the technique or instruments used has been provided to determine a root cause for this failure. If any additional information is obtained, this complaint will be re-opened to capture that information. At this point in time, no corrective action is required, and no further action is warranted. However, (b)(4) will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field. Udi: unavailable. Depuy synthes has been informed that the catalog number and lot number are not available.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameUNKNOWN FMS PRODUCT
Type of DeviceUnknown
Manufacturer (Section D)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
MDR Report Key7299790
MDR Text Key101484632
Report Number1221934-2018-50240
Device Sequence Number1
Product Code GES
Combination Product (y/n)N
PMA/PMN Number
UNK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 02/01/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/27/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK FMS PRODUCT
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/07/2018
Is This a Reprocessed and Reused Single-Use Device? No

-
-