MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL SPEEDTRAP WHITE 30MM; POLYETHYLENE SUTURE

Model Number	223747
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).The lot number is unknown.
Event or Problem Description
It was reported by the affiliate that during an unknown procedure the speedtrap white 30mm failed to deploy.Additional information could not be provided regarding the event outcome, patient status, or if the device will be returned.

• Brand Name: SPEEDTRAP WHITE 30MM
• Common Device Name: POLYETHYLENE SUTURE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 9619427
• Report Number: 1221934-2020-00276
• Device Sequence Number: 585701
• Product Code: GAT
• UDI-Device Identifier: 10886705027149
• UDI-Public: 10886705027149
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K161638
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/13/2020

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: Health Professional
• Device Model Number: 223747
• Device Catalogue Number: 223747
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2020
• Initial Report FDA Received Date: 01/22/2020
• Patient Sequence Number: 1