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

Catalog Number	36102
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that the drainage hole of the device had not been punched.
Additional Manufacturer Narrative
Upon further review, bard medical has determined that this mdr was initially reported in error on a 3500a form.According to bard medical division's reportability guidelines the event is a non-reportable event.
Event or Problem Description
It was reported that the drainage hole of the device had not been punched.

• Brand Name: ROCHESTER MEC WIDEBAND M 100BX
• Common Device Name: 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
• MDR Report Key: 6659920
• Report Number: 1018233-2017-03249
• Device Sequence Number: 10774236
• Product Code: NNX
• UDI-Device Identifier: 00801741070983
• UDI-Public: (01)00801741070983(17)211028(10)JUAY0418
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2017

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/28/2021
• Device Catalogue Number: 36102
• Device Lot Number: JUAY0418
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2017
• Initial Date Received by Manufacturer: 05/31/2017
• Supplement Date Received by Manufacturer: 07/07/2017
• Initial Report FDA Received Date: 06/22/2017
• Supplement Report FDA Received Date: 07/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1