MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-03-09 for WK210B manufactured by Medline Industries Inc..
[101987590]
It was reported that during an emergency c-section, a blade detached from a handle and fell into the surgical site, requiring an additional procedure in order to retrieve. The blade detached from the handle during the procedure and reportedly fell onto the surgical field. It was determined to be "ok" per the staff present during the procedure. After delivery, the staff "noticed the blade was not there. " a c-arm x-ray was performed which showed the blade "was inside the bladder appearing to be floating. " a urologist was called in to perform an emergency extraction of the blade. The blade involved in this incident was reportedly discarded and was not returned to the manufacturer for evaluation. Information regarding the handle used during this incident is unknown. No other patient, procedural, or product information was reported to the manufacturer. Due to the need for additional surgical intervention in order to retrieved the blade, this medwatch is being filed. If additional relevant information becomes available a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[101987591]
It was reported that during an emergency c-section, a blade detached from a handle and fell into the surgical site, requiring an additional procedure in order to retrieve.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423395-2018-00011 |
| MDR Report Key | 7326881 |
| Report Source | USER FACILITY |
| Date Received | 2018-03-09 |
| Date of Report | 2018-03-09 |
| Date of Event | 2018-02-26 |
| Date Mfgr Received | 2018-02-28 |
| Date Added to Maude | 2018-03-09 |
| 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 | NIGEL VILCHES |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD IL 60093 |
| Manufacturer Country | US |
| Manufacturer Postal | 60093 |
| Manufacturer Phone | 2249311458 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | PACK C-SECTION-KENNESTONE |
| Product Code | OHM |
| Date Received | 2018-03-09 |
| Catalog Number | WK210B |
| Lot Number | 17LB1064 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES INC. |
| Manufacturer Address | THREE LAKES DRIVE NORTHFIELD IL 60093 US 60093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-03-09 |