MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other,study report with the FDA on 2018-06-19 for PHASIX MESH 1190400 manufactured by Davol Inc., Sub. C.r. Bard, Inc..
[111563778]
Based on the information provided at this time, no conclusion can be made as to the degree to which the mesh implant used to treat the patient may have caused or contributed to the patient's current symptoms. It appears that there is a cascade of medical issues related to the identified hernia recurrence. Recurrence is a known inherent risk of hernia repair surgery. The adverse reaction section of the instructions-for-use identifies recurrence as a possible complication, additionally the warning section states, "to prevent recurrences when repairing hernias, the phasix? Mesh must be large enough to provide sufficient overlap beyond the margins of the defect. Careful attention to mesh fixation placement and spacing will help prevent excessive tension or gap formation between the mesh and fascial tissue. " a review of the manufacturing records showed no issues associated to the reported event. All process steps were completed per manufacturing and inspection procedures. Product passed all required inspections at each step at end product level. There was no manufacturing abnormalities noted. Should additional information be provided, a supplemental mdr will be submitted. Note: the information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard. Remains implanted.
Patient Sequence No: 1, Text Type: N, H10
[111563779]
Event was reported via post market clinical study. On (b)(6) 2016 the patient underwent the repair of an infraumbilical hernia with 2 stomas present. An endoscopic retro-rectus with component separation technique and removal of excess skin were performed. The wound and fascia were closed with absorbable suture. The skin was fully closed. On (b)(6) 2017 during a follow up visit the patient was noted to have a normal scar, small peristomal hernia (assessed by the clinician as not related to the device and not related to the procedure) at simoideostomy, and a normal urosotmy. The patient experienced daily vomiting and abdominal colic pain from mid (b)(6) 2018. It is noted that the vomiting might be caused by adhesions as a result of surgery. On (b)(6) 2018 the patient was diagnosed with a recurrence of the incisional hernia. The event is assessed by the clinician as ongoing, severe and possibly related to the device. The event is assessed by the clinician as definitely related to the procedure. On (b)(6) 2018 the patient had become severely dehydrated and was admitted to her local hospital for evaluation and re-hydration. She was discharged (b)(6) 2018 with a referral for further evaluation and treatment. On (b)(6) 2018 the patient was seen at outpatient clinic where a gastroscopy and ct was prescribed. Gastroscopy was performed (b)(6) 2018 and was inconclusive. Ct was also performed and was evaluated at conference (b)(6) 2018. The ct revealed a recurrence of the incisional hernia resulting in partial obstruction of the small bowel. The patient is awaiting surgery to take place to repair the hernia.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1213643-2018-02047 |
| MDR Report Key | 7616109 |
| Report Source | FOREIGN,OTHER,STUDY |
| Date Received | 2018-06-19 |
| Date of Report | 2018-07-11 |
| Date of Event | 2018-06-01 |
| Date Mfgr Received | 2018-06-21 |
| Device Manufacturer Date | 2015-11-24 |
| Date Added to Maude | 2018-06-19 |
| 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 | LAURA SUNDBERG |
| Manufacturer Street | 100 CROSSINGS BLVD. |
| Manufacturer City | WARWICK RI 02886 |
| Manufacturer Country | US |
| Manufacturer Postal | 02886 |
| Manufacturer Phone | 4018258462 |
| Manufacturer G1 | BARD SHANNON LIMITED -3005636544 |
| Manufacturer Street | SAN GERONIMO INDUSTRIAL PARK LOT #1, ROAD #3, KM 79.7 |
| Manufacturer City | HUMACAO PR 00791 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00791 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PHASIX MESH |
| Generic Name | SURGICAL MESH |
| Product Code | OOD |
| Date Received | 2018-06-19 |
| Model Number | NA |
| Catalog Number | 1190400 |
| Lot Number | HUZJ1532 |
| Device Expiration Date | 2017-10-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DAVOL INC., SUB. C.R. BARD, INC. |
| Manufacturer Address | 100 CROSSINGS BLVD. WARWICK RI 02886 US 02886 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2018-06-19 |