MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,other report with the FDA on 2013-03-08 for ETHIBOND EXTRA & EXCEL POLYESTER SUTURE manufactured by Ethicon, Inc..
[3194507]
It was reported that the patient underwent a gynecological procedure to treat pelvic organ prolapse and cystocele on (b)(6) 2009 and mesh was used. The sutures were utilized and reportedly eroded post-operatively. The patient experienced pain, inflammation, infection, dissolving and erosion of the mesh and sutures, urinary and bowel problems, dyspareunia, erosion of her internal tissues, and she has undergone additional surgeries and revisionary procedures including a mesh revision surgery on (b)(6) 2009. The patient had a mesh explantation surgery on (b)(6) 2011 due to erosion. No additional information is provided at this time.
Patient Sequence No: 1, Text Type: D, B5
[10529198]
(b)(4). Conclusion: no conclusion can be drawn at this time. Should additional information be obtained, a supplemental 3500a form will be submitted accordingly. This is one of three medwatches being submitted. See also medwatch 2210968-2013-02283 and medwatch 2210968-2013-02284. The same patient is represented in each medwatch.
Patient Sequence No: 1, Text Type: N, H10
[13451452]
It was reported that following insertion the patient experienced pain, extrusion, infection, urinary problems and vaginal scarring. It was reported that the patient underwent mesh revision on (b)(6) 2009 due to erosion. It was reported that the patient underwent vaginal mesh excision with enterocele repair w/ biologic graft on (b)(6) 2011 due to severe vaginal pain. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[105875430]
Diabetes mellitus
Patient Sequence No: 1, Text Type: N, H10
[105875431]
.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2013-02285 |
| MDR Report Key | 2995204 |
| Report Source | 00,OTHER |
| Date Received | 2013-03-08 |
| Date of Report | 2013-02-11 |
| Date Mfgr Received | 2017-11-07 |
| Date Added to Maude | 2013-03-08 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. KATHY RICE |
| Manufacturer Street | 4545 CREEK ROAD MAIL LOCATION 120 |
| Manufacturer City | CINCINNATI OH 45242 |
| Manufacturer Country | US |
| Manufacturer Postal | 45242 |
| Manufacturer Phone | 5133373299 |
| Manufacturer G1 | NI |
| Manufacturer Street | NI |
| Manufacturer City | NI NI |
| Manufacturer Postal Code | NI |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ETHIBOND EXTRA & EXCEL POLYESTER SUTURE |
| Generic Name | SUTURES, NON ABSORBABLE |
| Product Code | GAS |
| Date Received | 2013-03-08 |
| Model Number | NA |
| Catalog Number | NI |
| Lot Number | NI |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON, INC. |
| Manufacturer Address | ROUTE 22 WEST PO BOX 151 SOMERVILLE NJ 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-03-08 |