MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-29 for SURGICAL CONVENIENCE KIT 2108 E manufactured by Synergy Health North America.
[93884493]
The reported event occurred during the setup for patient procedure. A pack of new sterile towels were brought into the room subsequently causing a delay in the start of the patient procedure. Staff at synergy health were made aware of the reported event and received training. The dress code at synergy health was reviewed and no changes were required. The root cause of the reported event could not be determined.
Patient Sequence No: 1, Text Type: N, H10
[93884494]
The user facility reported that a hair was found in between a pack of eight (8) sterile towels.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001527607-2017-00002 |
| MDR Report Key | 7067043 |
| Date Received | 2017-11-29 |
| Date of Report | 2017-11-29 |
| Date of Event | 2017-11-02 |
| Date Mfgr Received | 2017-11-03 |
| Date Added to Maude | 2017-11-29 |
| 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. MARINELA CEBIC |
| Manufacturer Street | 7086 INDUSTRIAL ROW ROAD |
| Manufacturer City | MASON OH 45040 |
| Manufacturer Country | US |
| Manufacturer Postal | 45040 |
| Manufacturer Phone | 5133986406 |
| Manufacturer G1 | SYNERGY HEALTH NORTH AMERICA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SURGICAL CONVENIENCE KIT |
| Generic Name | FIBER, MEDICAL ABSORBENT |
| Product Code | FRL |
| Date Received | 2017-11-29 |
| Model Number | 2108 E |
| Catalog Number | 2108 E |
| Lot Number | 950510 |
| ID Number | NI |
| Operator | NURSE |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNERGY HEALTH NORTH AMERICA |
| Manufacturer Address | 7086 INDUSTRIAL ROW ROAD MASON OH 45040 US 45040 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-29 |