MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-30 for SURGIMED 606-400-009 manufactured by Tei Bioscience Inc. / Integra Lifesciences.
[71684859]
Use surgimed (collagen matrix for soft tissue reconstruction), 3 cases out of 4 caused delay wound healing and patients returned to operating room for interventions. All 4 cases were done by different surgeons. We cannot attribute a cause and effect relationship but our surgeons have decided to stop using the product. Date of procedure: (b)(6) 2016; surgimed; model: surgimed ref 606-400-009; lot number: 1511004; serial number: none. Provisional diagnosis: erosion of other implanted mesh and other prosthetic materials to surrounding. Date of procedure: (b)(6) 2016; surgimed; model: surgimed ref 606-400-016; size 25cm x 40cm; lot number: 1601020; serial number: none. Provisional diag: unspecified abdominal hernia without obstruction or gangrene. Date of procedure: (b)(6) 2016; surgimed, model: surgimed ref 606-400-009; size 13cm x 25cm; lot number: 1608015; serial number: none. Provisional diag: ventral hernia without obstruction of gangrene. Reference report numbers: mw5068785 and mw5068786.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5068787 |
| MDR Report Key | 6450440 |
| Date Received | 2017-03-30 |
| Date of Event | 2016-10-11 |
| Date Added to Maude | 2017-03-31 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | PHARMACIST |
| 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 | 0 |
| Brand Name | SURGIMED |
| Generic Name | COLLAGEN MATRIX FOR SOFT TISSUE |
| Product Code | KGN |
| Date Received | 2017-03-30 |
| Model Number | 606-400-009 |
| Lot Number | 1608015 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TEI BIOSCIENCE INC. / INTEGRA LIFESCIENCES |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-03-30 |