MAUDE Adverse Event Report: CL MEDICAL I-STOP; VAGINAL TAPE

Lot Number IS-14-04

Device Problems Detachment Of Device Component (1104); Difficult to Insert (1316)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/07/2014

Event Type  malfunction  

Event Description

Surgeon using vaginal tape for incontinence; experienced product failure with i-stop polypropylene non absorbable tape when inserter passers on each end of the tape came off as they were being passed through the body.

• Brand Name: I-STOP
• Type of Device: VAGINAL TAPE
• Manufacturer (Section D): CL MEDICAL; sainte foy les lyon 69110
• MDR Report Key: 3949763
• MDR Text Key: 4642915
• Report Number: MW5037314
• Device Sequence Number: 1
• Product Code: OTN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2014
• Device Lot Number: IS-14-04
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Weight: 91