MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-08-18 for SERI SURGICAL SCAFFOLD SCF10X25AGEN 94675 manufactured by Sofregen, Inc.
[83058553]
Patient Sequence No: 1, Text Type: N, H10
[83058554]
On (b)(6) 2017, a case was received from the fda (report number: mw5070605). It reported the following: surgery to include seri mesh scaffold (allergan manufactured) since now they have sold to sofregen medical, since initial install on (b)(6) 2015-leading to infection which has resulted in (continued) multiple surgeries to remove, efforts to correct damaging effects from the medical device and long term antibiotics. On (b)(6) 2017, the reporter was called and a message was left requesting additional information. On (b)(6) 2017, the reporter called and stated she had thick case file regarding the issues she has experienced. She is willing to share the information with sofregen and will email the information she is willing to share. On (b)(6) 2017 she shared the following information. Procedure date: (b)(6) 2015: operations performed: abdominal wall reinforcement with 10 x 15 cm biological mesh, bilateral implantable doppler placement, and multilevel intercostal nerve blockade with 20 mg of liposomal bupivacaine of chest and abdomen for postoperative analgesia. The findings from these procedures as they pertain to seri are as follows: attention was then turned to closing the abdomen. The abdominal fascia was closed in a layered fashion using a ethibond suture. One piece of 10 x25 cm biological mesh was then overlaid over the fascial repair and inset using 0 ethibond sutures. The patient was then flexed in a beach-chair position. The superior abdominal flap was then tailor tacked to the lower abdominal flap and the umbilicus was inset through a separate chevron incision using 4-6 monocryl and 5-0 prolene sutures. The umbilicus was pink and viable at the completion of the inset. The abdomen was then closed in a layered fashion using #2 quill pdo sutures to close the scarpa fascia, followed by 3-0 pds v-loc sutures in the subticular plane. Two 19-french round drains were placed in the abdomen through separate stab incisions and anchored to the skin using 2-0 prolene sutures. (continued on page 4)
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8020862-2017-00011 |
| MDR Report Key | 6804910 |
| Report Source | CONSUMER |
| Date Received | 2017-08-18 |
| Date of Report | 2017-08-18 |
| Date of Event | 2015-10-02 |
| Date Mfgr Received | 2017-07-19 |
| Date Added to Maude | 2017-08-18 |
| 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 | 200 BOSTON AVE. SUITE 1100 |
| Manufacturer City | MEDFORD MA 021554288 |
| Manufacturer Country | US |
| Manufacturer Postal | 021554288 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SERI SURGICAL SCAFFOLD |
| Generic Name | SERI SURGICAL SCAFFOLD |
| Product Code | OXF |
| Date Received | 2017-08-18 |
| Model Number | SCF10X25AGEN |
| Catalog Number | 94675 |
| Lot Number | P14091501A |
| Device Expiration Date | 2017-10-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SOFREGEN, INC |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-08-18 |