MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-09-13 for ROUND FILTER POLYPROPYLEN MD344 manufactured by Aesculap Ag.
[120185881]
(b)(4). The device has not been returned for evaluation; therefore investigation results are not available. If new information becomes available, a supplemental report will be sent.
Patient Sequence No: 1, Text Type: N, H10
[120185882]
It was reported that the filter has a set pattern of holes. The contents of set has been eliminated as a cause for the holes in the filter du to pattern and set having clearance. Also, sets had few to/no instruments (retractor blades). No patient injury. Delay of surgery of 20 minutes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916714-2018-00024 |
| MDR Report Key | 7874188 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-09-13 |
| Date of Report | 2018-09-13 |
| Date of Event | 2018-08-15 |
| Date Facility Aware | 2018-08-28 |
| Date Mfgr Received | 2018-08-16 |
| Date Added to Maude | 2018-09-13 |
| 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 | MRS 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 USA |
| Manufacturer Street | 615 LAMBERT POINTE DRIVE |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 63042 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ROUND FILTER POLYPROPYLEN |
| Generic Name | DISPOSABLES CONTAINER SYSTEM |
| Product Code | KCT |
| Date Received | 2018-09-13 |
| Model Number | MD344 |
| Catalog Number | MD344 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2018-09-13 |