MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-24 for CPO-6 manufactured by Coopersurgical, Inc..
[124961056]
Cooper surgical inc. Is currently investigating the reported complaint condition. The actual device involved in the complaint cannot be returned because it was discarded by the user. Once the investigation is completed and a follow-up report will be filed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[124961057]
On (b)(6) 2018, (b)(4) medical received 3 cases of the patient infection after the surgery using the cpo-6 from one hospital. Hospital name: (b)(6) hospital; lot numbers and the surgery dates: 247608 - (b)(6), 248879 - (b)(6) / (b)(6) ( 1 each). The surgeon is the experienced doctor both on the surgery and the product. The reason of the infection is suspected both from the product or in-hospital reasons. In order to clarify the root cause, hospital is requesting to certify that the product was properly sterilized. The used products are discarded. The other items of these lots are brought back to ken medical. The used products ( on recall ) were well inspected and the pouch problem was not observed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1216677-2018-00064 |
| MDR Report Key | 8002388 |
| Date Received | 2018-10-24 |
| Date of Report | 2018-10-24 |
| Date of Event | 2018-10-01 |
| Date Mfgr Received | 2018-10-23 |
| Device Manufacturer Date | 2018-07-31 |
| Date Added to Maude | 2018-10-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. PETER NIZIOLEK |
| Manufacturer Street | 75 CORPORATE DRIVE |
| Manufacturer City | TRUMBULL CT 06611 |
| Manufacturer Country | US |
| Manufacturer Postal | 06611 |
| Manufacturer G1 | COOPERSURGICAL, INC. |
| Manufacturer Street | 75 CORPORATE DRIVE |
| Manufacturer City | TRUMBULL CT 06611 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06611 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CPO-6 |
| Generic Name | CPO-6 |
| Product Code | HEW |
| Date Received | 2018-10-24 |
| Model Number | CPO-6 |
| Catalog Number | CPO-6 |
| Lot Number | 248879 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOPERSURGICAL, INC. |
| Manufacturer Address | 75 CORPORATE DRIVE TRUMBULL CT 06611 US 06611 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2018-10-24 |