MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-24 for PNEUMOPERITONEUM INSUFFLATION NEEDLE - 120MM LENGTH PN120 manufactured by Ethicon Endo-surgery, Llc..
[26891052]
(b)(4). When additional information is received and/or the device analysis has been completed, a supplemental medwatch will be sent.
Patient Sequence No: 1, Text Type: N, H10
[26891053]
It was reported that the packaging is flaking. As you peel apart the packaging, the flaking started and it did compromise the sterility of the product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005075853-2015-06106 |
| MDR Report Key | 5101847 |
| Date Received | 2015-09-24 |
| Date of Report | 2015-09-11 |
| Date Mfgr Received | 2015-09-18 |
| Date Added to Maude | 2015-09-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MILTON GARRETT |
| Manufacturer Street | 4545 CREEK ROAD ML 120A |
| Manufacturer City | CINCINNATI OH 45242 |
| Manufacturer Country | US |
| Manufacturer Postal | 45242 |
| Manufacturer Phone | 5133378865 |
| Manufacturer G1 | ETHICON ENDO-SURGERY, LLC |
| Manufacturer Street | 475 CALLE C |
| Manufacturer City | GUAYNABO PR 00969 |
| Manufacturer Postal Code | 00969 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PNEUMOPERITONEUM INSUFFLATION NEEDLE - 120MM LENGTH |
| Product Code | FDP |
| Date Received | 2015-09-24 |
| Model Number | NA |
| Catalog Number | PN120 |
| Lot Number | G4U116 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON ENDO-SURGERY, LLC. |
| Manufacturer Address | 475 CALLE C GUAYNABO PR 00969 00969 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-09-24 |