MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-08 for UNKNOWN PELVICOL PRODUCT UNK PELVICOL manufactured by Covidien, Formerly Tissue Science Labor.
[59455065]
(b)(4). (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[59455066]
Procedure: urogynecological. The patient's attorney alleged a deficiency against the device resulting in an unspecified adverse outcome. Product was used for therapeutic treatment.
Patient Sequence No: 1, Text Type: D, B5
[69140624]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[69140625]
On (b)(6) 2013: mild urinary and mild fecal incontinence, constipation, bloating dysfunction, incomplete bladder emptying, mild cystocele, pelvic pain, uti. Erosion of a uretex sup stitch that was removed in (b)(6) 2004 chronic pain in the pelvis. Urinary leakage associated with physical activity (jumping, coughing, laughing). On (b)(6) 2016: stress urinary incontinence, cystocele-midline, urethral hypermobility, interstitial cystitis, bladder pain, chronic cystitis, urinary urgency, pelvic pain. Additional implant (using advantage fit) surgery: on (b)(6) 2016: underwent retropubic mid urethral sling (advantage fit), anterior colporrhaphy, cystoscopy with hydrodistention, trigger point injection-3 pelvic muscles for stress urinary incontinence, cystocele-midline, urethral hypermobility, interstitial cystitis, bladder pain, chronic cystitis, urinary urgency, urinary hesitancy, pelvic pain under general anesthesia.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9617613-2016-00079 |
| MDR Report Key | 6087724 |
| Date Received | 2016-11-08 |
| Date of Report | 2016-10-12 |
| Date of Event | 2004-05-14 |
| Date Mfgr Received | 2016-11-04 |
| Date Added to Maude | 2016-11-08 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SHARON MURPHY |
| Manufacturer Street | 60 MIDDLETOWN AVE |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal | 06473 |
| Manufacturer G1 | COVIDIEN, FORMERLY TISSUE SCIENCE LABOR |
| Manufacturer Street | VICTORIA HOUSE, VICTORIA ROAD |
| Manufacturer City | ALDERSHOT, HAMPSHIRE |
| Manufacturer Country | UK |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN PELVICOL PRODUCT |
| Generic Name | UNKNOWN PELVICOL |
| Product Code | PAI |
| Date Received | 2016-11-08 |
| Model Number | UNK PELVICOL |
| Catalog Number | UNK PELVICOL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN, FORMERLY TISSUE SCIENCE LABOR |
| Manufacturer Address | VICTORIA HOUSE, VICTORIA ROAD ALDERSHOT, HAMPSHIRE UK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-11-08 |