| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ALIGN TO URETHRAL SUPPORT SYSTEM - HALO | ALIGN TO URETHRAL SUPPORT SYSTEM - HALO | BARD SHANNON LIMITED -3005636544 | OTN | NA | BRD500HL | HUSB0928 | R | N |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2013-08-23 | 0 | 1. R |
Patient 1
(B)(4). IT WAS REPORTED BY THE PT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PT HAS EXPERIENCED SIGNIFICANT SEVERE AND PERMANENT PHYSICAL PAIN, SUFFERING, DISABILITY, PHYSICAL IMPAIRMENT, SUSTAINED PERMANENT INJURY, AND HAS UNDERGONE MEDICAL TREATMENT.
Patient 1
THE PRODUCT FAMILY FOR THIS WOMEN'S HEALTHCARE PRODUCT IS UNK; THEREFORE, WE ARE UNABLE TO DETERMINE THE ASSOCIATED LABELING AND (B)(4) TO REVIEW. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. "LAWYER-FILED REPORT - (B)(6)."
Patient 1
THE SAMPLE WAS NOT RETURNED. THE FINISHED PRODUCT MET ALL SPECIFICATIONS PRIOR TO BEING RELEASED FOR GENERAL DISTRIBUTION. THE INSTRUCTIONS FOR USE WHICH ACCOMPANIES ALL DEVICES CURRENTLY ADDRESSES POTENTIAL RISKS ASSOCIATED WITH SURGICALLY IMPLANTED MATERIALS. THE INSTRUCTIONS FOR USE STATES IN THE ADVERSE EVENTS: COMPLICATIONS ASSOCIATED WITH THE PROPER IMPLANTATION OF THE ALIGN? TO URETHRAL SUPPORT SYSTEM MAY INCLUDE, BUT ARE NOT LIMITED TO: POSTOPERATIVE HEMATOMA, WHICH MAY OCCUR FOLLOWING THE IMPLANT PROCEDURE, TEMPORARY URINARY RETENTION, BLADDER OUTLET OBSTRUCTION, AND VOIDING DIFFICULTIES ASSOCIATED WITH OVER-CORRECTION/TOO MUCH TENSION PLACED ON THE MESH SLING IMPLANT, PERFORATIONS OR LACERATIONS OF VESSELS, NERVES, BLADDER OR ANY VISCERA, WHICH MAY OCCUR DURING INTRODUCER NEEDLE PASSAGE,TRANSITORY IRRITATION AT THE OPERATIVE WOUND SITE, WHICH MAY ELICIT A FOREIGN BODY RESPONSE THAT LEADS TO INFLAMMATION, INFECTION, OR EROSION OF THE IMPLANT. (B)(4).
Patient 1
PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED PELVIC PAIN, VAGINAL DRAINAGE, PAINFUL PRESSURE, PAINFUL INTERCOURSE, RECURRENCE OF THE ORIGINAL PROBLEM, MESH EROSION, MESH EXTRUSION, LEAKAGE WHEN SHE SNEEZES, URINARY PROBLEMS AND SLING EROSION WITH SUBSEQUENT EXCISION OF ERODED SLING. ADDITIONALLY HER BLADDER FEELS FULL ALL THE TIME AND SHE MUST GET UP IN THE MIDDLE OF THE NIGHT.