MAUDE Adverse Event Report: TISSUE SCIENCE LABORATORIES MESH TSL - PELVICOL¿; MESH, SURGICAL, POLYMERIC

Model Number PEL220

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

Patient Problems Abdominal Pain (1685); Incontinence (1928); Pain (1994); Urinary Retention (2119); Urinary Frequency (2275); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, multiple medical complications occurred after implant of the device.The product used for therapeutic treatment of genital ptosis characterized by a large externalized rectocele.Stage 2 cystocele and stage 2 hysteroptosis were noted.It was reported that after implant, the patient experienced lower abdominal/lumbar/sacrum/rectum pain, un-emptied bladder, incompletely empty bladder sensation, and frequent urination.After a post-operative cesarean section, the patient continues to experience urinary/rectal problems, painful bending, appendicitis-like pains, and tugging/shearing pain.The patient has had rectal manometry, mri, and echo, with no results to explain the pain.The patient has also had a sub-total hysterectomy/bilateral salpingectomy preserving the cervix/ovaries/collar, but the symptoms are the same.

• Brand Name: MESH TSL - PELVICOL¿
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): TISSUE SCIENCE LABORATORIES; victoria house, victoria road; aldershot, hampshire GU11 1EJ; GB GU11 1EJ
• Manufacturer (Section G): TISSUE SCIENCE LABORATORIES; victoria house, victoria road; aldershot, hampshire GU11 1EJ; GB GU11 1EJ
• Manufacturer Contact: lisa hernandez ; 60 middletown ave.; north haven, CT 06473 ; 2034925563
• MDR Report Key: 8570553
• MDR Text Key: 143737510
• Report Number: 9617613-2019-00062
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PEL220
• Device Catalogue Number: PEL220
• Device Lot Number: 08B06-3
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/05/2019
• Initial Date FDA Received: 05/01/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention