MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-16 for PROBE DE 6 SERLING 10-8-ST manufactured by Integra York, Pa Inc..
[28865096]
To date the device involved in the reported incident has not been received for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
[28865097]
Customer initially reports that during the first wash all probes were discolored. In use, user realized they were peeling off causing residues in the wound which required them to clean out the wound again. (b)(6) 2015 customer reports event occurred (b)(6) 2015. They were inserting a plain packing strip in wound when nurses saw residues and removed it right after. No harm done to patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523190-2015-00106 |
| MDR Report Key | 5157817 |
| Date Received | 2015-10-16 |
| Date of Report | 2015-10-02 |
| Date of Event | 2015-07-01 |
| Date Mfgr Received | 2015-10-16 |
| Date Added to Maude | 2015-10-16 |
| 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 | USER SANDRA LEE |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | INTEGRA YORK, PA INC. |
| Manufacturer Street | 589 DAVIES DRIVE |
| Manufacturer City | YORK PA 17402 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 17402 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PROBE DE 6 SERLING |
| Generic Name | M5 - GENERAL SURGERY |
| Product Code | FGM |
| Date Received | 2015-10-16 |
| Catalog Number | 10-8-ST |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA YORK, PA INC. |
| Manufacturer Address | 589 DAVIES DRIVE 589 DAVIES DRIVE YORK PA 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-10-16 |