MAUDE Adverse Event Report: TISSUE SCIENCE LABORATORIES UNKNOWN PELVICOL PRODUCT; MESH, SURGICAL, POLYMERIC

Model Number UNK PELVICOL

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

Patient Problems Herpes (1898); Incontinence (1928); Itching Sensation (1943); Abnormal Vaginal Discharge (2123); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Incident date was not provided.Lot number not provided udi not provided.Re-processing information not provided since the lot number was not provided, this information cannot be determined.

Event Description

The patient's attorney alleged a deficiency against the device resulting in an unspecified adverse outcome.Product was used for therapeutic treatment.The preoperative and postoperative diagnosis was stress urinary incontinence with anterior vaginal wall defect.The procedure performed was an anterior vaginal wall repair and suburethral sling.

Manufacturer Narrative

Corrected information: date of birth, no eval explain code.If information is provided in the future, a supplemental report will be issued.

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,social history: concomitant implant: na postoperative complications: still has discharge and has a single suture which has not fallen out yet.Some detrusor instability (di) but really not much - stress incontinence, cystocele.(b)(6) 2008 - underwent panniculectomy for panniculitis under general endotracheal tube anesthesia (geta).

• Brand Name: UNKNOWN PELVICOL PRODUCT
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): TISSUE SCIENCE LABORATORIES; victoria house, victoria road; aldershot, hampshire GU11 1EJ; GB GU11 1EJ
• MDR Report Key: 6423834
• MDR Text Key: 70539282
• Report Number: 9617613-2017-05042
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K992556
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• 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: 03/22/2017
• 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
• Date Manufacturer Received: 03/24/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 35 YR