MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-15 for DYNJ0428947F manufactured by Stryker.
[117430775]
It was reported that in the middle of bilateral breast tissue expander exchange to implants and fat grafting procedure, prior to the closing of the surgical site, irrigation was required to successfully remove lint coming from the lap sponges. Per report, the lint from the lap sponges was also found on drapes and staff's gloves. Reportedly, the lap sponges were not inspected for lint prior to use. General anesthesia was used; however, there was no report of any adverse patient consequence and no effect on the patient's stability as a result of the incident. No impact to the patient, the procedure, or the total length of the procedure was reported. There was no serious injury or follow up care reported related to the event. Due to the reported incident and in an abundance of caution, this medwatch is being filed. The sample was not available to be returned for evaluation. A third party notification has been completed with the manufacturer of the lap sponges involved with this event. No additional information is available. If additional information becomes available, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[117430776]
It was reported that prior to the closing of the surgical site, irrigation was required to successfully remove lint coming from the lap sponges.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423395-2018-00047 |
| MDR Report Key | 7784939 |
| Date Received | 2018-08-15 |
| Date of Report | 2018-08-15 |
| Date of Event | 2018-08-02 |
| Date Mfgr Received | 2018-08-07 |
| Date Added to Maude | 2018-08-15 |
| 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 | BERMON PUNZALAN |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD IL 60093 |
| Manufacturer Country | US |
| Manufacturer Postal | 60093 |
| Manufacturer Phone | 2249311514 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Generic Name | STRYKER LAP SPONGES IN BREAST ABDOMINOPLASTY TRAY |
| Product Code | FTN |
| Date Received | 2018-08-15 |
| Catalog Number | DYNJ0428947F |
| Lot Number | 18FKE327 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER |
| Manufacturer Address | 2825 AIRVIEW BOULEVARD KALAMAZOO MI 49002 US 49002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-08-15 |