MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. ZO.O. SLINGS, CLIP

Device Problems Break (1069); Off-Label Use (1494); Inadequate or Insufficient Training (1643)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

(b)(4).

Manufacturer Narrative

(b)(4).This appears to be a "malfunction" type of event not because there was a technical malfunction of the device, but since due to a use error the device did not perform as intended.Additional info will be provided following the conclusion of the manufacturer's investigation.

• Brand Name: SLINGS, CLIP
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. ZO.O.; ul. ks. wawrzyniaka 2; komorniki 6205 2; PL 62052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. ZO.O.; ul. ks. wawrzyniaka 2; komomiki 0000 6205; PL 000062052
• Manufacturer Contact: pamela wright ; 12625 235more; suite 308; san antonio, TX 78247 ; 2102787040
• MDR Report Key: 3952100
• MDR Text Key: 4638501
• Report Number: 3007420694-2014-00072
• Device Sequence Number: 1
• Product Code: IKX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Remedial Action: Notification
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Date Manufacturer Received: 06/05/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2013
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1