MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-03-29 for UPSYLON? Y MESH KIT M0068318220 manufactured by Boston Scientific - Marlborough.
[103912991]
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown. The device has not been received for analysis. Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed. (b)(4). The kit was implanted at (b)(6) hospital.
Patient Sequence No: 1, Text Type: N, H10
[103912992]
It was reported to boston scientific corporation that an upsylon y-mesh was implanted in the patient on (b)(6) 2018. According to the complainant, around (b)(6) 2018, the patient developed severe back pain. On (b)(6) 2018, she was diagnosed with l5 to s1 epidural abscess and was treated with washout and laminectomy. However, sepsis continued to worsen. The patient returned to the operating room on (b)(6) 2018 for the removal of surgical mesh. Epidural, vaginal and upsylon y-mesh cultures showed growth of serratia marcescens.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2018-00845 |
| MDR Report Key | 7384250 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-03-29 |
| Date of Report | 2018-03-06 |
| Date of Event | 2018-02-17 |
| Date Mfgr Received | 2018-03-06 |
| Date Added to Maude | 2018-03-29 |
| 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 | EMP. NANCY CUTINO |
| Manufacturer Street | 100 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086834000 |
| Manufacturer G1 | PROXY BIOMEDICAL LIMITED |
| Manufacturer Street | COILLEACH SPIDDAL |
| Manufacturer City | GALWAY |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UPSYLON? Y MESH KIT |
| Generic Name | GYNECOLOGIC LAPAROSCOPE AND ACCESSORIES |
| Product Code | OHD |
| Date Received | 2018-03-29 |
| Model Number | M0068318220 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC - MARLBOROUGH |
| Manufacturer Address | 100 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-03-29 |