MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-26 for PDS II CTX 2-0 D8588 manufactured by Ethicon, Llc.
[185054739]
The patient had a primary c-section and, then, there was concern for bleeding underneath fascia and the abdomen had to be reopened. This was performed under general anesthesia. The abdomen was reopened and at closing, two needles broke off near the tip and x-ray had to be done-which was negative for any retained needle. The patient was not harmed by this event. This information was reported to the company representative. Lot # ml5588 and pg11885.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9882494 |
| MDR Report Key | 9882494 |
| Date Received | 2020-03-26 |
| Date of Report | 2020-02-18 |
| Date of Event | 2020-01-19 |
| Report Date | 2020-02-20 |
| Date Reported to FDA | 2020-02-20 |
| Date Reported to Mfgr | 2020-03-26 |
| Date Added to Maude | 2020-03-26 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Brand Name | PDS II CTX 2-0 |
| Generic Name | SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE |
| Product Code | NEW |
| Date Received | 2020-03-26 |
| Model Number | D8588 |
| Catalog Number | D8588 |
| Lot Number | ML5588 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON, LLC |
| Manufacturer Address | HIGHWAY 183 KM. 8.3 SAN LORENZO PR 00754 US 00754 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other; 3. Required No Informationntervention | 2020-03-26 |