MAUDE Adverse Event Report: COVIDIEN, FORMERLY TISSUE SCIENCE LABOR UNKNOWN PELVICOL PRODUCT

Model Number UNK PELVICOL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Incontinence (1928); Injury (2348); Hematuria (2558)

Event Date 05/09/2002

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(6).User facility is listed in initial reporter.(b)(4).

Event Description

The patient's attorney alleged a deficiency against the device resulting in an unspecified adverse outcome.

Manufacturer Narrative

Tracking number: (b)(4).A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Alleged complications post device implant, microscopic hematuria-small amount, stress urinary incontinence, urgency and difficulty with urination.Intervention surgery occurred (b)(6) 2012; cystoscopy and fulguration of small hemangioma.

Manufacturer Narrative

Medtronic complaint report: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Per additional information received, the preoperative and postoperative diagnosis was stress urinary incontinence, cystocele.Underwent pubovaginal sling and anterior repair under general plus local infiltration anesthesia.

• Brand Name: UNKNOWN PELVICOL PRODUCT
• Type of Device: UNKNOWN PELVICOL
• Manufacturer (Section D): COVIDIEN, FORMERLY TISSUE SCIENCE LABOR; victoria house, victoria road; aldershot, hampshire ; UK
• Manufacturer (Section G): COVIDIEN, FORMERLY TISSUE SCIENCE LABOR; victoria house, victoria road; aldershot, hampshire ; UK
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven
• MDR Report Key: 6108894
• MDR Text Key: 60092661
• Report Number: 9617613-2016-00087
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNK PELVICOL
• Device Catalogue Number: UNK PELVICOL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 52 YR