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 2016-04-11 for MONOMAX VIOLET 1(4)200CM HRT48 LOOP(M B0041231 manufactured by Aesculap Ag.
[42374613]
(b)(4). Manufacturing site evaluation: evaluation on-going. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[42374614]
Country of complaint: (b)(6). Inner foil is welded with outer foil. Opening, sterilization and withdrawal is not possible.
Patient Sequence No: 1, Text Type: D, B5
[44729837]
Samples received: there are no samples available. Analysis and results: as no batch number is available, the batch manufacturing record cannot be reviewed. Without any closed sample an analysis cannot be carried out in order to make a decision. 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. We regret any inconvenience this issue may have caused and thank you for your collaboration. Actions on product distributed of this reference/batch: based on the conclusion derived from investigation, it is not required to take action 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
| Report Number | 2916714-2016-00281 |
| MDR Report Key | 5568489 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-04-11 |
| Date of Report | 2016-05-06 |
| Date of Event | 2016-03-07 |
| Date Facility Aware | 2016-04-11 |
| Date Mfgr Received | 2016-03-12 |
| Date Added to Maude | 2016-04-11 |
| 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)200CM HRT48 LOOP(M |
| Generic Name | SUTURES |
| Product Code | NWJ |
| Date Received | 2016-04-11 |
| Model Number | B0041231 |
| Catalog Number | B0041231 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2016-04-11 |