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 2020-03-26 for SAFIL VIOLET 3/0 (2) 70CM HR22 C1048030 manufactured by B. Braun Surgical, S.a..
[185196094]
Analysis and results: there are no previous complaints of this code batch of which we manufactured and distributed in the market (b)(4) units. There are no units in stock in b. Braun surgical's warehouse. As no samples have been received and no units are available in b. Braun surgical (b)(4). We have only reviewed the batch manufacturing record and the results during the process fulfill usp/ep and b. Braun surgical requirements. For your information, biocompatibility of safil? Has been tested in numerous experiments. In sensibilisation and irritation tests the harmlessness of safil? Was proved. As stated in the instructions for use (ifu) of safil: "mode of action: when safil? Suture materials are employed there is a mild inflammatory reaction, which is typical for an endogenous reaction to a foreign body. As time passes the suture material is encapsulated by fibrous connective tissue". Nevertheless there are risks (side effects) associated to the use of safil? Suture, which are typical for any (absorbable) suture and which are mentioned in the ifu of safil? : "side effects: as with all other suture materials long contact with salt solutions, such as urine and bile, can lead to lithiasis. As for all sutures after implantation a transient inflammation, temporary irritation and infection at the wound site may occur occasionally. Existing infections may occasionally be enhanced by any foreign body. An occasional wound dehiscence and granulation may not be excluded. " 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 and the case is not confirmed due to lack of evidence. 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 our 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
[185196095]
It was reported that there was an issue with safil violet suture. The client reported that there was redness and swelling at the suture site on the second day after surgical procedure. Additional data has not been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003639970-2020-00173 |
| MDR Report Key | 9884814 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-03-05 |
| Date Mfgr Received | 2020-03-11 |
| Device Manufacturer Date | 2018-05-29 |
| Date Added to Maude | 2020-03-26 |
| 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 S OR |
| Manufacturer Street | CARRETERA DE TERRASSA, 121 |
| Manufacturer City | RUB 08191 |
| Manufacturer Country | SP |
| Manufacturer Postal | 08191 |
| Manufacturer G1 | B. BRAUN SURGICAL, S.A. |
| Manufacturer Street | CARRETERA DE TERRASSA, 121 |
| Manufacturer City | RUB 08191 |
| Manufacturer Country | SP |
| Manufacturer Postal Code | 08191 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SAFIL VIOLET 3/0 (2) 70CM HR22 |
| Generic Name | SYNTHETIC ABSORBABLE BRAIDED SUTURE |
| Product Code | GAM |
| Date Received | 2020-03-26 |
| Model Number | C1048030 |
| Catalog Number | C1048030 |
| Lot Number | 118222 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | B. BRAUN SURGICAL, S.A. |
| Manufacturer Address | CARRETERA DE TERRASSA, 121 RUB?, 08191 SP 08191 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-26 |