MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2015-05-22 for MONOMAX VIOLET 1 (4) 150CM HR48 LOOP (M) B0041119 manufactured by Aesculap Ag & Co. Kg.
[5818274]
Country of complaint: (b)(6). Abdomen burst after 1 week, was sutured with monomax. During the re-operation; no remnants of the suture were found.
Patient Sequence No: 1, Text Type: D, B5
[13300135]
Manufacturing site investigation: samples received: no samples available. There are no previous complaints of this code batch. (b)(6) units of this batch code were manufactured and distributed. There are no units in oem stock. Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfill oem requirements. Monomax is degraded by hydrolysis and via enzymatic pathways. The degradation process leads to a successive decrease of the material's tensile strength and finally to a complete mass absorption of the fiber. The mass absorption of monomax is essentially completed in between 13 months and more than 36 months, depending on the size of the suture material and the perfusion of the tissue in which the suture is implanted. In the warning notes/precautionary measures from the instructions for use of the product is it also explained that: monomax should be used applying the standard surgical suturing and knotting techniques, taking into account the surgeon's experience with the respective surgical procedure. Care should be taken that the knots are positioned properly and adequate knot security is given. A minimum of 4 correctly placed square and flat knots should be done. When working with monomax suture material, great care should be taken to avoid any crushing or crimping damage of the monofilament by instruments such as forceps or needle holders. Corrective/preventive actions: not applicable.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2916714-2015-00432 |
| MDR Report Key | 4795744 |
| Report Source | 01,07 |
| Date Received | 2015-05-22 |
| Date of Report | 2015-05-21 |
| Date Mfgr Received | 2015-04-22 |
| Date Added to Maude | 2015-06-18 |
| 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 |
| Manufacturer G1 | B.BRAUN SURGICAL SA |
| Manufacturer Street | 121 CARRETERA DE TERRASSA |
| Manufacturer City | RUBI (BARCELONA), ES 08191 |
| 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 HR48 LOOP (M) |
| Generic Name | SUTURE |
| Product Code | NWJ |
| Date Received | 2015-05-22 |
| Model Number | B0041119 |
| Catalog Number | B0041119 |
| Lot Number | 114415 |
| Operator | HEALTH PROFESSIONAL |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP AG & CO. KG |
| Manufacturer Address | TUTTLINGEN, DE 78532 78532 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-05-22 |