MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2015-02-18 for MONOMAX VIOLET 1 (4) 150CM HR48 LOOP (M) B0041119 manufactured by B. Braun Surgical S.a..
[5514825]
Country of complaint: (b)(6). Monomax suture caused a suture sinus and development of infection after 14 months post caesarian section (b)(6) 2013. Non-diabetic patient. Entire c-sec was done smoothly and was uneventful even after delivery. The 1st (1 week post op) and subsequent post-natal (1 month post op) indicated no complication. Monomax suture was used to close the patient's rectus sheath and before monomax being introduced, they were using dafilion to close that layer. (b)(6) 2014, patient came back to hospital and claimed that the suture was causing suture sinus and infection. Patient had seen general practitioner and the doctor pulled yellowish suture from patient, believed to be monomax suture. Operation to remove remaining undissolve suture completed, sent for bacteria culture, (b)(6) was found to be present.
Patient Sequence No: 1, Text Type: D, B5
[12957780]
Manufacturing site evaluation: evaluation on-going at original equipment manufacturer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2916714-2015-00114 |
| MDR Report Key | 4540608 |
| Report Source | 01,07 |
| Date Received | 2015-02-18 |
| Date of Report | 2015-02-18 |
| Date Mfgr Received | 2015-01-19 |
| Date Added to Maude | 2015-03-19 |
| 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 |
| 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 | SYNTHETIC ABSORBABLE SUTURE |
| Product Code | NWJ |
| Date Received | 2015-02-18 |
| Model Number | B0041119 |
| Catalog Number | B0041119 |
| Lot Number | 113292 |
| 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 S.A. |
| Manufacturer Address | RUBI, (BARCELONA), ES 08191 08191 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-02-18 |