MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-08-21 for GENTRIX SURGICAL MATRIX THICK PSMT1620 manufactured by Acell, Inc..
[117769375]
This mdr is being submitted due to the reported suture pull through that occurred during the initial placement of the acell device. The device was therefore not used, the surgeon requested and used a device from a different manufacturer which resulted in a delay (increased surgery time). The patient did not experience any complication due to the suture pull through. The device was returned to acell for further investigation, suture pull through could not be duplicated on the device. A review of the manufacturing records for this lot identified no deviations in the production process that fall outside of specification. The device was manufactured and distributed sterile in compliance with acell's operating procedures and federal, state, and local laws and regulations.
Patient Sequence No: 1, Text Type: N, H10
[117769376]
On (b)(6) 2018, acell, inc. Became aware that suture pull through occurred with an acell device during the reinforcement of a incisional hernia repair. Contrary to the device's instructions for use (ifu), the device was hydrated for 25 minutes and in a 100 deg fahrenheit warmer. The ifu specifies to hydrate the device in a sterile dish with room temperature sterile saline for a minimum of 30 minutes and maximum 60 minutes. The surgeon secured one side of the mesh with a 1 ctx braided suture; however, when the surgeon began to secure the other side down, the suture pulled through on the initially secured side of the device. The device was not used. The surgeon requested and used a device from a different manufacturer which resulted in a surgical delay (increased surgery time). The patient did not experience any complication due to the suture pull through nor the increased surgery time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005920706-2018-00011 |
| MDR Report Key | 7802057 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-08-21 |
| Date of Report | 2018-07-23 |
| Date of Event | 2018-07-23 |
| Date Mfgr Received | 2018-07-23 |
| Device Manufacturer Date | 2017-01-16 |
| Date Added to Maude | 2018-08-21 |
| 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 | MR. BARRY BRAINARD |
| Manufacturer Street | 6640 ELI WHITNEY DR. |
| Manufacturer City | COLUMBIA MD 21046 |
| Manufacturer Country | US |
| Manufacturer Postal | 21046 |
| Manufacturer Phone | 4109538558 |
| Manufacturer G1 | ACELL, INC. |
| Manufacturer Street | 6640 ELI WHITNEY DR. |
| Manufacturer City | COLUMBIA MD 21046 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 21046 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GENTRIX SURGICAL MATRIX THICK |
| Generic Name | GENTRIX SURGICAL MATRIX THICK |
| Product Code | OXH |
| Date Received | 2018-08-21 |
| Returned To Mfg | 2018-07-24 |
| Model Number | PSMT1620 |
| Catalog Number | PSMT1620 |
| Lot Number | 010957 |
| Device Expiration Date | 2019-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACELL, INC. |
| Manufacturer Address | 6640 ELI WHITNEY DR COLUMBIA MD 21046 US 21046 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2018-08-21 |