MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-14 for PNEUMO MATIC INSUFFLATION NEEDLE 900-210 manufactured by Cooper Surgical.
[83032117]
Two (2) cooper surgical, pneumo-matic insufflation needles did not pass co2 pressure test with dr. (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5071641 |
| MDR Report Key | 6800875 |
| Date Received | 2017-08-14 |
| Date of Report | 2017-08-14 |
| Date of Event | 2017-08-11 |
| Date Added to Maude | 2017-08-17 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PNEUMO MATIC INSUFFLATION NEEDLE |
| Generic Name | INSUFFLATION NEEDLE |
| Product Code | FHO |
| Date Received | 2017-08-14 |
| Model Number | 900-210 |
| Catalog Number | 900-210 |
| Lot Number | 186236 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOPER SURGICAL |
| Manufacturer Address | TRUMBULL CT 06611 US 06611 |
| Brand Name | PNEUMO MATIC INSUFFLATION NEEDLE |
| Generic Name | INSUFFLATION NEEDLE |
| Product Code | FHO |
| Date Received | 2017-08-14 |
| Lot Number | 213729 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | COOPER SURGICAL |
| Manufacturer Address | TRUMBILL CT 06611 US 06611 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-08-14 |