MAUDE Adverse Event Report: DAVOL SURGICAL INNOVATIONS -9616067 ROCHESTER MEC WIDEBAND I 100BX

Catalog Number 36103

Device Problems Incorrect Measurement (1383); Defective Component (2292)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.

Event Description

It was reported that the measurements of the device were allegedly too short.

Manufacturer Narrative

Upon further review, bard medical has determined that this mdr was initially reported in error as this event is not reportable.

Event Description

It was reported that the measurements of the device were allegedly too short.

• Brand Name: ROCHESTER MEC WIDEBAND I 100BX
• Type of Device: MEC
• Manufacturer (Section D): DAVOL SURGICAL INNOVATIONS -9616067; ave. roberto fierro #6408; parque industrial aeropuerto; cd. juarez, chih s.a. de c.v. 32690 ; MX 32690
• Manufacturer (Section G): DAVOL SURGICAL INNOVATIONS -9616067; ave. roberto fierro #6408; parque industrial aeropuerto; cd. juarez, chih s.a. de c.v. 32690 ; MX 32690
• Manufacturer Contact: amy gravley ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 6338101
• MDR Text Key: 67936989
• Report Number: 1018233-2017-00516
• Device Sequence Number: 1
• Product Code: NNX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 12/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/28/2021
• Device Catalogue Number: 36103
• Device Lot Number: JUAY0419
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/27/2017
• Initial Date FDA Received: 02/16/2017
• Supplement Dates Manufacturer Received: 12/19/2017
• Supplement Dates FDA Received: 12/19/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1