MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2015-05-27 for MONOMAX VIOLET 1(4) 150CM LOOP (M) B0041077 manufactured by B. Braun Surgical S.a..
[5892278]
Country of complaint: (b)(6). After use of the suture monomax there was dehiscence in the closure of an aponeurosis evidenced. Fraying of the thread was noted.
Patient Sequence No: 1, Text Type: D, B5
[13283852]
Manufacturing site evaluation: samples received: 2 unopened pouches. There are no previous complaints of this code batch; (b)(6) units of this code batch were manufactured and distributed. Tightness test to the samples received has been performed and the units are tight. Knot pull tensile strength testing of the samples received was performed and the results fulfill the requirements of the oem. Linear pull tensile strength of the samples received was tested and the results are within specification. Degradation test (24 hours in hcl 3m solution at 37? C) has been conducted with the samples received and the results fulfill product specification. Samples obtained from qc stock were subjected to the same testing as the samples from the customer and all test results were within specification. Products performed according to specification. No corrective/ preventive action required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2916714-2015-00448 |
| MDR Report Key | 4809168 |
| Report Source | 01,07 |
| Date Received | 2015-05-27 |
| Date of Report | 2015-05-27 |
| Date of Event | 2014-12-18 |
| Date Mfgr Received | 2015-04-28 |
| Date Added to Maude | 2015-06-23 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | NICOLE BROYLES |
| Manufacturer Street | 615 LAMBERT POINTE DR |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3145515988 |
| Manufacturer G1 | B. BRAUN SURGICAL SA |
| Manufacturer Street | 121 CARRETERA DE TERRASSA |
| Manufacturer City | RUBI (BARCELONA) 08191 |
| Manufacturer Country | ES |
| Manufacturer Postal Code | 08191 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MONOMAX VIOLET 1(4) 150CM LOOP (M) |
| Generic Name | SUTURE |
| Product Code | NWJ |
| Date Received | 2015-05-27 |
| Model Number | B0041077 |
| Catalog Number | B0041077 |
| Lot Number | 114353 |
| Device Expiration Date | 2019-08-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | B. BRAUN SURGICAL S.A. |
| Manufacturer Address | RUBI (BARCELONA), ES |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-05-27 |