MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2016-07-11 for G6313, L ALEXIS O C-SEC RET 5/BX 101356801 manufactured by Amr.
[49231061]
The g6313, l alexis o c-sec ret 5/bx procode and common device name are kga/kna. No product is being returned for evaluation and no lot # has been provided to manufacturer. A follow up report will be sent once the results have been analyzed. In accordance to 21 cfr 803. 56, if we obtain additional information, which was not known or was not available when the initial report was submitted, then the supplemental report will be submitted to the fda.
Patient Sequence No: 1, Text Type: N, H10
[49231062]
"there were 2 cases which bladder rupture occurred by using c-section(g6313). One case was premature labor and adhesion was not seen during surgery. The other was a repeated cesarean section case with multiple delivery. Adhesion was seen after abdominal section; by partly detaching the adhesion, c-section was applied. After the surgery, bladder rupture occurred. There are no health problems to both mother and children except for bladder rupture. G6313 is applied at this facility since 2013, used for only high risk cases. This was the first case that bladder rupture occurred so we would like to report this case. Date of incident and lot# are unknown. " patient status - "bladder rupture". Additional information received on july 6, 2016 from (b)(6): by the way, regarding the second case, the details are as follows. The situation and corresponding treatment after the incident is quite same as the former case on (b)(6). Date of incident : (b)(6) 2016; device used in the case : alexis o c-section (g6313). Details of case: patient : (b)(6) pregnant; emergency c-section; the surgeon made a horizontal incision and found adhesion on uterine corpus then, broke up the adhesion to some extent and placed alexis o c-section. After suturing the uterus, checked inside of abdominal cavity with laparoscope and found exposure of a urethral catheter. Urology surgeon sutured the damaged site and confirmed no leakage after suturing. A week later, no leakage was confirmed by angiography of bladder.
Patient Sequence No: 1, Text Type: D, B5
[71064404]
The event unit was not returned for evaluation. The complainant's experience stated that the alexis? O c-section retractor was used on a patient with adhesions. Applied medical's instructions for use (ifu) states that "use of the alexis c-section retractor is contraindicated for women with significant adhesions. " this contraindication was present on the ifu that was submitted to the (b)(4) distributor for product registration in (b)(6). During the investigation of the event, applied medical was made aware that the contraindication stated above was not included in the (b)(4) distributor's local translated version of the ifu at the time of the procedure. It is possible that this omission contributed to the event. The ifu has since been updated by the (b)(4) distributor to include the contraindication against use of the alexis o c-section retractor on patients with adhesions.
Patient Sequence No: 1, Text Type: N, H10
[71064405]
Additional information received via email july 26, 2016 7:21 am from (b)(6) - "i traveled with (b)(4), product manager and area sales manager, (b)(4) on (b)(6) for the initial meeting with dr. (b)(6). Dr. (b)(6) seemed to be feeling down and wondering what really caused two urinary bladder injuries. I recall her comment for these two cases as follows: case 1: premature delivery, no adhesion. Case 2: triplet, severe adhesion. She asked us where precisely alexis o rings should be placed, if she should have avoided a case with adhesion and etc. Unfortunately and to my great regret, none of us were aware that it was contraindicated for sever adhesion case nor it was not reflected in medical leaders (b)(6) ifu on that day. Anyway, as far as i remember, only one case had adhesion but not the other. " additional information received via email from (b)(6) on august 23, 2016: it is confirmed that adhesions were present in both events. Medical leaders will not report to (b)(6) because the surgeons confirmed that these cases were not caused by the products.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027111-2016-00509 |
| MDR Report Key | 5784253 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2016-07-11 |
| Date of Report | 2017-03-21 |
| Date of Event | 2016-05-25 |
| Date Mfgr Received | 2016-06-13 |
| Date Added to Maude | 2016-07-11 |
| 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 Street | 22872 AVENIDA EMPRESA |
| Manufacturer City | RANCHO SANTA MARGARITA CA 92688 |
| Manufacturer Country | US |
| Manufacturer Postal | 92688 |
| Manufacturer Phone | 9497138233 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | G6313, L ALEXIS O C-SEC RET 5/BX |
| Generic Name | KGA/KNA |
| Product Code | KGA |
| Date Received | 2016-07-11 |
| Model Number | G6313 |
| Catalog Number | 101356801 |
| Lot Number | UNKNOWN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMR |
| Manufacturer Address | 22872 AVENIDA EMPRESA RANCHO SANTA MARGARITA CA 92688 US 92688 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2016-07-11 |