MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2018-12-19 for MONOMAX VIOLET 1 (4) 200CM HR48 LOOP(M) B0041325 manufactured by B Braun Surgical Sa.
[131339129]
(b)(4). When additional information is received a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[131339130]
It was reported by the healthcare professional "the surgeon was performing a hysterectomy on a patient who has had 3 multiparous and has ca grade 3. During the procedure while performing the second knotting the suture broke, causing a delay in surgery when the surgeon had to complete the surgery with another suture. " additional patient information and verify delay time of surgery has been requested. When additional information is received a follow up report will be submitted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003639970-2018-00799 |
| MDR Report Key | 8182168 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-12-19 |
| Date of Report | 2019-01-22 |
| Date Facility Aware | 2019-01-17 |
| Date Mfgr Received | 2019-01-17 |
| Date Added to Maude | 2018-12-19 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. NICOLE BROYLES |
| Manufacturer Street | 615 LAMBERT POINTE DRIVE |
| 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, 08191 |
| Manufacturer Country | SP |
| Manufacturer Postal Code | 08191 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MONOMAX VIOLET 1 (4) 200CM HR48 LOOP(M) |
| Generic Name | SYNTHETIC ABSORBABLE MONOFILAR |
| Product Code | NWJ |
| Date Received | 2018-12-19 |
| Model Number | B0041325 |
| Catalog Number | B0041325 |
| Lot Number | 117411 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | B BRAUN SURGICAL SA |
| Manufacturer Address | 121 CARRETERA DE TERRASSA RUBI, 08191 SP 08191 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-19 |