MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-03 for MONOMAX VIOLET 0(3.5)150CM HR40SLOOPM B0041076 manufactured by B.braun Surgical Sa.
[47746047]
(b)(4). Manufacturing site evaluation: evaluation on-going. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[47746048]
Country of complaint: (b)(6). Thread broke after surgery.
Patient Sequence No: 1, Text Type: D, B5
[55136990]
Samples received: none. Analysis and results: there are no previous complaints of this code batch. Two cases were received at the same time from the same customer. Approx (b)(4) units of this product were manufactured and distributed in the market, there are no units in stock. Without any sample a proper analysis cannot be performed. Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfill the oem requirements. Remarks: described in literature, wound dehiscence can be caused by poor surgical techniques such as improper suturing, over-tightened sutures or inappropriate type of sutures. Wound dehiscence can also be caused by increased stress to the wound area as a result of strenuous exercise, heavy lifting, coughing, laughing, sneezing, vomiting or bearing down too hard with bowel movement. In some cases, wound dehiscence could be secondary to wound infection or poor healing as seen in patients with chronic diseases, malnutrition or weak immune systems. Secondary wound dehiscence can occur in patients with (b)(6), renal disease, diabetes mellitus and those undergoing chemotherapy or radiotherapy. Steroids inhibit primary wound healing and delay the formation of granulation tissue. Final conclusion: complaint is not justified. Without samples a study can not be performed to see if the affected product does not fulfill the oem requirements. Note is taken of this incidence and if any samples are received in the future, the case will be re-opened and analyzed. Please note that when no samples are received analyzing is very limited. 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
| Report Number | 2916714-2016-00467 |
| MDR Report Key | 5697631 |
| Date Received | 2016-06-03 |
| Date of Report | 2016-09-02 |
| Date Facility Aware | 2016-06-03 |
| Date Mfgr Received | 2016-07-21 |
| Date Added to Maude | 2016-06-03 |
| 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 0(3.5)150CM HR40SLOOPM |
| Generic Name | SUTURES |
| Product Code | NMJ |
| Date Received | 2016-06-03 |
| Model Number | B0041076 |
| Catalog Number | B0041076 |
| Lot Number | 115054 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2016-06-03 |