MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2015-03-27 for MONOMAX VIOLET 1(4) 200CM HRT48 LOOP(M B0041231 manufactured by B. Braun Surgical S.a..
[5601109]
Country of complaint: (b)(6). Monomax loop tore during suture of abdominal wall. There were two cases reported in the hospital with this code/batch. One x general surgery. One x urology.
Patient Sequence No: 1, Text Type: D, B5
[13097778]
Manufacturing site evaluation: samples received: 1 unopened pouch. There are no previous complaints of this code batch. No units in oem stock. Tightness test to sample received has been performed and the unit is tight. Tested the knot pull tensile strength of the sample received and the result fulfills the requirements of the oem. Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfilled oem requirements. Actions on product: not applicable. Corrective/preventive actions: not applicable.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2916714-2015-00247 |
| MDR Report Key | 4647848 |
| Report Source | 01,07 |
| Date Received | 2015-03-27 |
| Date of Report | 2015-03-23 |
| Date Mfgr Received | 2015-02-23 |
| Date Added to Maude | 2015-05-11 |
| 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 DRIVE |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3145515988 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MONOMAX VIOLET 1(4) 200CM HRT48 LOOP(M |
| Generic Name | SYNTHETIC SUTURE |
| Product Code | NWJ |
| Date Received | 2015-03-27 |
| Model Number | B0041231 |
| Catalog Number | B0041231 |
| Lot Number | 114371 |
| Device Expiration Date | 2019-09-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | B. BRAUN SURGICAL S.A. |
| Manufacturer Address | RUBI (BARCELONA) SP |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-03-27 |