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 2015-11-19 for MONOMAX VIOLET 0 (3,5) 150CM HR26 (M) B0041441 manufactured by Aesculap Ag.
[31610964]
(b)(4). Manufacturing site evaluation: samples received: 151 unopened pouches and 4 opened. Analysis and results: there are no previous complaints of this code batch, there are no units in stock. Received 151 closed samples and 4 open samples, only with the second pack opened. The open samples received do not have the aluminium pouch stuck to the outer paper foil, but there are signs of first pack (aluminium pouch) sealed to the second pack (paper foil). On the other hand, when opening the closed samples received, some of them have the first pack sealed to the second pack in the area of the 4th welding. This defect took place in the welding machine and these units were not sorted out by the personnel involved in this process. Final conclusion: complaint is justified. Actions on distributed product of this reference/batch: replace this code/batch to the end customer or refund. Corrective/preventive actions: this complaint will be included in the analysis of trending, and corrective action will be open if applies.
Patient Sequence No: 1, Text Type: N, H10
[31610965]
Country of complaint: (b)(6). A new packages is the inner foil welded with outer foil (batch (b)(4)). First pack sealed to 2nd pack.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916714-2015-01023 |
| MDR Report Key | 5236189 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2015-11-19 |
| Date of Report | 2015-11-19 |
| Date of Event | 2015-10-27 |
| Date Facility Aware | 2015-11-06 |
| Date Mfgr Received | 2015-10-27 |
| Device Manufacturer Date | 2015-01-01 |
| Date Added to Maude | 2015-11-19 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| 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 | AESCULAP AG |
| Manufacturer Street | PO BOX 40 |
| Manufacturer City | TUTTLINGEN, 78501 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78501 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MONOMAX VIOLET 0 (3,5) 150CM HR26 (M) |
| Generic Name | SUTURES |
| Product Code | NWJ |
| Date Received | 2015-11-19 |
| Model Number | B0041441 |
| Catalog Number | B0041441 |
| Lot Number | 115113V004 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP AG |
| Manufacturer Address | PO BOX 40 TUTTLINGEN, 78501 GM 78501 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-11-19 |