MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-27 for INSUFFLATION TUBING 0620-040-660 manufactured by Stryker Global Headquarters.
[50856400]
Insufflation tubing would not connect properly to insufflator. Tubing replaced with one that worked properly. No harm to pt. Mfr: please note that we do not send products to the mfr, but you may arrange for pick-up by calling my number below.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5063719 |
| MDR Report Key | 5832738 |
| Date Received | 2016-07-27 |
| Date of Report | 2016-07-19 |
| Date of Event | 2016-06-27 |
| Date Added to Maude | 2016-07-29 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | INSUFFLATION TUBING |
| Generic Name | INSUFFLATION TUBING |
| Product Code | NKC |
| Date Received | 2016-07-27 |
| Model Number | 0620-040-660 |
| Lot Number | 16C0131 |
| Device Expiration Date | 2019-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER GLOBAL HEADQUARTERS |
| Manufacturer Address | 2825 AIRVIEW BLVD. KALAMAZOO MI 49002 US 49002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-07-27 |