MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-24 for ENDOPATH PNEUMOPERITONEUM NDL PN150 manufactured by Ethicon Endo-surgery, Llc..
[26811553]
(b)(4). Information asked for but unknown or not provided during initial contact. When additional information is received and/or the device analysis has been completed, a supplemental medwatch will be sent. Additional information was requested and the following was obtained: can you please clarify whether or not the "packaging that was flaking" is referring to the external device carton or if it is referring to the internal device packaging meaning inside the blister pack itself. Was the sterility of the device compromised? As you peel apart the packaging, the flaking started and it did compromise the sterility of the product.
Patient Sequence No: 1, Text Type: N, H10
[26811554]
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
[30423216]
(b)(4). Upon review of the information provided, it was concluded that this event does not meet the fda defined criteria for a reportable event, and is being considered not reportable.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005075853-2015-06105 |
| MDR Report Key | 5101016 |
| Date Received | 2015-09-24 |
| Date of Report | 2015-09-11 |
| Date Mfgr Received | 2015-11-02 |
| 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 | 3 |
| Brand Name | ENDOPATH PNEUMOPERITONEUM NDL |
| Product Code | FDP |
| Date Received | 2015-09-24 |
| Model Number | NA |
| Catalog Number | PN150 |
| Lot Number | G4U116 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 |