MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07,08 report with the FDA on 2015-05-19 for IDRT, UNKNOWN XXX-IDRT manufactured by Integra Lifesciences Corp..
[5817604]
This is the second 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
[13333546]
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
[63876106]
Integra has completed their internal investigation on 06/15/2015. Methods: review of device history records, review of complaint history. Results: dhr review- the reported product lot associated with this complaint for idrt-ts 4x5 is lot# 105nb0283659. This finished goods product lot stems from parent dispersion lot# 105n00281170. The manufacture date for this lot is 06/2013 and date of expiry is 06/2015. 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. A review of complaint history from april 2014- april 2015 was performed. Four complaints were identified, within the search timeframe, including the current complaint. There were approximately (b)(4)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 (b)(4). 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 patients, as all patients 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 patients. In all cases, the infections were treated successfully and the outcome was satisfactory without the need to remove the integra implant or to apply any further integra or other product.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1121308-2015-00010 |
| MDR Report Key | 4788048 |
| Report Source | 01,05,07,08 |
| Date Received | 2015-05-19 |
| Date of Report | 2015-04-29 |
| Date Mfgr Received | 2015-04-29 |
| Device Manufacturer Date | 2013-06-01 |
| 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 | MGR |
| Date Received | 2015-05-19 |
| Catalog Number | XXX-IDRT |
| Lot Number | 105N00281170 |
| Device Expiration Date | 2015-06-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 |