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 2020-03-31 for PROLENE*BLUE 3-0 45CM (1)SC-24 8184T manufactured by Ethicon Inc..
[186695183]
(b)(4). A manufacturing record evaluation was performed for the finished device, and no non-conformances were identified. To date the device has not been returned. If the device or further details are received at the later date a supplemental medwatch will be sent. The patient demographic info: age, gender, weight, bmi at the time of index procedure on what tissue what the suture used? What was the tissue condition, i. E. Normal or thin, calcified, fragile, diseased? What instruments were used to grasp the needle? Where was the needle grasped during use? Was the entire device removed from the patient on (b)(6) 2020? Does the piece/device remain retained in the patient? S tissue? If the pieces were retained, where is the device located/in what structure? Other relevant patient history/concomitant medications. Will the actual device be returned for evaluation? Will representative samples from the same lot be returned for evaluation? What is physician? S opinion as to the etiology of or contributing factors to this event?
Patient Sequence No: 1, Text Type: N, H10
[186695184]
It was reported that the patient underwent a c-section procedure on (b)(6) 2020 and the suture was used for skin closure. While at the right angle of a surgical wound, there was a rupture/breakage of the needle in the proximal third. It was also reported that more than half the needle was retain in the patient. Exploration of the surgical wound was performed with soft tissue ultrasound and rx intraoperative abdomen without finding the needle. It was reported that the patient had to be re-operated on (b)(6) 2020 in order to extract the needle which was found in the subcutaneous tissue. The patient had to stay one more day in the hospital. The patient was well and released on (b)(6) 2020. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2020-02500 |
| MDR Report Key | 9908223 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-03 |
| Date of Event | 2020-03-02 |
| Date Mfgr Received | 2020-03-03 |
| Device Manufacturer Date | 2019-08-19 |
| Date Added to Maude | 2020-03-31 |
| 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 | KARA DITTY-BOVARD |
| Manufacturer Street | P.O. BOX 151, ROUTE 22 WEST |
| Manufacturer City | SOMERVILLE NJ 08876 |
| Manufacturer Country | US |
| Manufacturer Postal | 08876 |
| Manufacturer Phone | 6107428552 |
| Manufacturer G1 | ETHICON INC.-BRAZIL |
| Manufacturer Street | RODOVIA PRESIDENTE DUTRA KM 154 |
| Manufacturer City | SAO PAOLO 12240 |
| Manufacturer Country | BR |
| Manufacturer Postal Code | 12240 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROLENE*BLUE 3-0 45CM (1)SC-24 |
| Generic Name | SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE |
| Product Code | GAW |
| Date Received | 2020-03-31 |
| Catalog Number | 8184T |
| Lot Number | AM5324 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON INC. |
| Manufacturer Address | P.O. BOX 151, ROUTE 22 WEST SOMERVILLE NJ 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-31 |