MAUDE Adverse Event Report: COVIDIEN

Model Number UNK WC

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

Submit date: 10/16/17.An investigation is currently underway; upon completion the results will be forwarded.

Event Description

The customer states that the gauze was falling apart and falling into the patient in the operative site.

Manufacturer Narrative

Based on the follow up information received, this incident has been reported in error because as per fda guidelines, the product was used in a veterinary setting, therefore it is not a reportable event.If information is provided in the future, a supplemental report will be issued.

• Manufacturer (Section D): COVIDIEN; 15 hampshire st.; mansfield MA 02048
• Manufacturer (Section G): COVIDIEN; 15 hampshire st.; mansfield MA 02048
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6952447
• MDR Text Key: 89416684
• Report Number: 3011410703-2017-00413
• Device Sequence Number: 1
• Product Code: FRO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNK WC
• Device Catalogue Number: UNK WC
• Device Lot Number: 16211A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/18/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other