MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07,08,company represent report with the FDA on 2015-05-19 for IDRT, UNKNOWN XXX-IDRT manufactured by Integra Lifesciences Corp..
[5859193]
This is the third of 3 complaints related to the same user facility, same issue, different occurrences. It was reported that 1 week after implantation of the product, the wound became infected with pseudomonas aeruginosa. "the burns and plastics (units) are using the products not only for full thickness burns but for other wounds such as diabetic ulcers. " comments from the consultant plastic surgeon, "i don't know how things have got to this stage! As i explained over the phone, we have had a few integra patients becoming infected recently. The infections always developed after the initial post-op dressing change. All the patients were fine at the first post-op dressing, indicating that there was no problem with the product or the operative technique used in theatre. The problem appears to be due to poor technique by certain nurses on the ward when carrying out subsequent dressing changes. I cannot give you the details requested as several patients are involved with different lots of integra used at different anatomical sites. In all cases to date the infections were treated successfully and the outcome was satisfactory without the need to remove the integra or to apply any further integra or other product. Apparently our so called link nurse reported the infections to a nurse in the infection control dept. From what i can gather, the latter contacted the manufacturer without first verifying what was going on with the medical staff. None of the medical staff, including both consultants, were ever contacted by the infection control dept. We were well aware of the problem and had already taken steps to remedy the situation by insisting with our nurses that strict sterile techniques were to be used when changing dressing or integra patients. I can assure you that to my knowledge there is no problem with the product and whether we like it or not we have to admit that there were serious shortcomings on the part of our ward nursing staff. "
Patient Sequence No: 1, Text Type: D, B5
[13333551]
The device will not be returned since it remains implanted. Based on reported information, integra has initiated an investigation.
Patient Sequence No: 1, Text Type: N, H10
[63943541]
Integra has completed their internal investigation 06/15/2015. Results- dhr review: the reported product lot associated with this complaint for idrt- ts 4x5 is lot #105b00279632. This finished goods product lot stems from parent dispersion lot #105000277865. The mfr date for this lot is 05-2013 and date of expire is 05-2015. Overall there were no issues identified during the batch record review that could be attributable to the failure mode of "infection" reported with the current complaint. The current investigation was initiated for idrt-ts 4x5 is lot #105b00279632. A lot query for this product lot (105b00279632) and the parent dispersion lot (105000277865) indicated that there were no other complaints found for these associated lots. This complaint is associated with an idrt-ts lot which is similar to idrt-sl and idrt-meshed products. There were approximately 1,571 units of these products sold in the past year (april 2014-april 2015). As per the trending query, there were four similar complaints identified for infection. Therefore, the calculated complaint rate is 0. 25%. Conclusion: the root cause is undetermined. As the product was not returned, the failure was unconfirmed. Additionally, there were no issues identified from the dhr review, trending and risk analysis that would have attributed to this complaint. Per the complaint background and according to the surgeon, neither the product nor the operative technique caused the infections with the integra pts, as all pts were fine after the initial post-op dressing. The surgeon attributes the failure to the lack of sterile techniques used by the nursing ward at the hospital during subsequent post-op dressing changes for the involved pts. In all cases, the infections were treated successfully and the outcome was satisfactory without the need to remove the integra implant of to apply any further integra or other product.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1121308-2015-00011 |
| MDR Report Key | 4788037 |
| Report Source | 01,05,07,08,COMPANY REPRESENT |
| Date Received | 2015-05-19 |
| Date of Report | 2015-04-29 |
| Date Mfgr Received | 2015-04-29 |
| Device Manufacturer Date | 2013-05-01 |
| Date Added to Maude | 2015-05-22 |
| 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 | MARIA LEONARD |
| Manufacturer Street | 311 ENTERPRISE DR |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362341 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IDRT, UNKNOWN |
| Generic Name | INTEGRA |
| Product Code | MDD |
| Date Received | 2015-05-19 |
| Catalog Number | XXX-IDRT |
| Lot Number | 105B00279632 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA LIFESCIENCES CORP. |
| Manufacturer Address | PLAINSBORO NJ 08536 US 08536 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-05-19 |