MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-02-06 for MONOMAX VIOLET 1(4)150CM HR40S LOOP(M) B0041077 manufactured by B.braun Surgical Sa.
[66675473]
(b)(4). Manufacturing site evaluation: evaluation on-going.
Patient Sequence No: 1, Text Type: N, H10
[66675474]
Country of complaint: (b)(6). It was reported that on two to three cases that the sutures used for abdominal valve closure have resulted in wound infection.
Patient Sequence No: 1, Text Type: D, B5
[73477433]
Samples received: none. Analysis and results: there are no previous complaints of this batch. 1,200 units of this product were manufactured and distributed in the market, there are no units in stock. As no samples have been received and no units are available in b. Braun surgical, s. A. We have only reviewed the batch manufacturing record and this product had a normal process and the results during the process fulfill b. Braun surgical requirements. As stated in the instructions for use of the product: "as for every other suture material, prolonged contact with salt solutions such as urine and bile can lead to lithiasis. The following side effects may be associated with the use of this product: transient local irritation, transient inflammatory foreign body reaction, enhanced bacterial infectivity, wound dehiscence, granulation, hardening of tissues (subcuticular sutures). Final conclusion: without samples we are not in position of studying if the affected product does not fulfil the specifications. In consequence, a proper analysis cannot be done. Nevertheless, we take note of this incidence and if any sample is received in the future, we will re-open the case and analyse it. Please note that when no samples are received our analysis is very limited. Actions on product distributed of this reference/batch: based on the conclusion derived from investigation, it is not required to make actions in distributed product. Corrective/preventive actions: according to internal procedures, there is no need to establish corrective or preventive actions. Nevertheless, this complaint is recorded for trending analysis to assess if actions are needed in the future.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003639970-2017-00044 |
| MDR Report Key | 6305892 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-02-06 |
| Date of Report | 2017-03-22 |
| Date of Event | 2017-01-09 |
| Date Facility Aware | 2017-01-24 |
| Date Mfgr Received | 2017-01-10 |
| Date Added to Maude | 2017-02-06 |
| 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 | 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, BARCELONA 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)150CM HR40S LOOP(M) |
| Generic Name | SUTURES |
| Product Code | NWJ |
| Date Received | 2017-02-06 |
| Model Number | B0041077 |
| Catalog Number | B0041077 |
| Lot Number | 114432 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | B.BRAUN SURGICAL SA |
| Manufacturer Address | 121 CARRETERA DE TERRASSA RUBI, BARCELONA 08191 SP 08191 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-02-06 |