MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2020-03-19 for OBTRYX SYSTEM - HALO M0068505000 850-500 manufactured by Boston Scientific Corporation.
[184098649]
(b)(4). The complainant indicated that the device remains implanted and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed. If any further relevant information is identified, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[184098650]
It was reported to boston scientific corporation that an obtryx system was implanted into the patient for the treatment of cystourethrocele, stress urinary incontinence (sui) and rectocele during a procedure performed on (b)(6) 2010. As reported by the patient's attorney, the patient was implanted with an additional sling (solyx) on (b)(6) 2012 due to a recurring stress urinary incontinence (sui). Boston scientific has been unable to obtain additional information regarding the event to date.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2020-00998 |
| MDR Report Key | 9852908 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-19 |
| Date of Event | 2012-02-03 |
| Date Mfgr Received | 2020-02-19 |
| Device Manufacturer Date | 2010-04-08 |
| Date Added to Maude | 2020-03-19 |
| 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 | CAROLE MORLEY |
| Manufacturer Street | 300 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086834015 |
| Manufacturer G1 | FREUDENBERG MEDICAL MIS INC |
| Manufacturer Street | 2301 CENTENNIAL BOULEVARD |
| Manufacturer City | JEFFERSONVILLE IN 47130 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47130 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OBTRYX SYSTEM - HALO |
| Generic Name | MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR |
| Product Code | OTN |
| Date Received | 2020-03-19 |
| Model Number | M0068505000 |
| Catalog Number | 850-500 |
| Lot Number | 1ML0030204 |
| Device Expiration Date | 2013-03-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | 300 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-19 |