MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-01-10 for SUTURE UNKNOWN manufactured by Ethicon Inc..
[96965071]
(b)(4). The international affiliate states the product code may possibly by mx69g (ethibond excel suture 30"(75cm) 2 grn) or 464h (pds ii polydioxanone suture). Additional information was requested and the following was obtained: confirm if needle broken and retained in patient is ethicon product. => it is unknown whether the needle is ethicon product or not. If yes, confirm which 1 of the 2 product codes reported and what lot # for broken needle retained in patient? => n/a. Confirm if there was any medical / surgical intervention done on patient to remove the needle? => no information. If yes, what was done? => n/a. If not, is it planned at a later date? => no information. What was the size of the needle used? => no information. Size of needle retained in the patient? => no information. If yes, what tissue structure is the needle located? => no information. Any patient consequences / adverse patient outcome as a result of needle retention? => no information. Any sample available to return for evaluation? => no sample is available to return. Patient's current condition? => no information.
Patient Sequence No: 1, Text Type: N, H10
[96965072]
It was reported that the patient underwent an unknown orthopedic surgery in (b)(6) 2017, and suture was used. It was reported that an image of a broken needle piece was detected in the body of the patient. Further details are not available.
Patient Sequence No: 1, Text Type: D, B5
[106727060]
Product complaint # ==> pc-000086130 corrected information:? Additional information was received that indicated this event now meets reporting criteria as serious injury. Corrected information patient code: (b)(4)- surgical intervention additional information: the broken needle piece remained in the patient? S body was removed. [surgeon? S comment] 4 types of needle-sutures were used in the primary operation. It is unknown which of them remained in the patient? S body. And the patient required the hospital to take the remaining foreign matter like a needle out and investigate it. The foreign matter with tissue were removed and sent to us to investigate. After we receive it and took photos, we are going to send the photos to you. Attempts are being made to obtain the following information. To date no response has been provided. If further details are received at a later date a supplemental medwatch will be sent. Can you confirm that the manufacturer of the device as ethicon? What date was the foreign matter with tissue removed? What tissue/ anatomical structure was the foreign body removed from? Do you have photos for review? Do you have the device/ foreign matter for evaluation? What is the current condition of the patient?
Patient Sequence No: 1, Text Type: N, H10
[106734568]
Product complaint # ==> pc-000086130 additional information was requested and the following was obtained: can you confirm that the manufacturer of the device as ethicon? => we cannot confirm if the manufacture of the device is ethicon. The returned samples of metal pieces seemed like tips of mx69g. However, it could not be confirmed if they were actually pieces of mx69g. What date was the foreign matter with tissue removed? => we couldn't get this information. What tissue/ anatomical structure was the foreign body removed from? => we couldn't get this information. Do you have photos for review? =>yes. Do you have the device/ foreign matter for evaluation? => yes, but the surgeon want to send back this piece of device. So we don't have this piece of device now because we sent back to the surgeon. What is the current condition of the patient? => no information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2210968-2018-70197 |
| MDR Report Key | 7180787 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-01-10 |
| Date of Report | 2018-01-31 |
| Date Mfgr Received | 2018-01-31 |
| Date Added to Maude | 2018-01-10 |
| 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 | DARLENE KYLE |
| Manufacturer Street | P.O. BOX 151, ROUTE 22 WEST |
| Manufacturer City | SOMERVILLE 088760151 |
| Manufacturer Country | US |
| Manufacturer Postal | 088760151 |
| Manufacturer Phone | 9082182792 |
| Manufacturer G1 | ETHICON INC. |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUTURE UNKNOWN |
| Generic Name | SUTURE, ABSORBABLE |
| Product Code | GAK |
| Date Received | 2018-01-10 |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON INC. |
| Manufacturer Address | P.O. BOX 151, ROUTE 22 WEST SOMERVILLE 088760151 US 088760151 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-01-10 |