MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-21 for BILAYER MATRIX WOUND DRESSING 8X10 SINGLE BMW8101 manufactured by Integra Lifesciences Corporation.
[40835093]
It was reported on (b)(6) 2016, the surgeon felt the patient was showing signs of an allergic reaction after the placement of the product on a full thickness wound. (no fever, but urticarial was present at the wound site - axilla/shoulder region). The product was placed on the patient five days prior, (b)(6) 2016, and dressed with acticoat and supplemental vac therapy - this is dr. (b)(6) normal regimen with idrt. No additional antibiotics or ointments were used. The product was removed (b)(6) 2016. During the removal procedure the surgeon took biopsies for histological evaluation. Results have not been provided at this time. It was reported patient injury is alleged - patient skin reaction.
Patient Sequence No: 1, Text Type: D, B5
[44499152]
Integra has completed their internal investigation on 22apr2016. In order to perform the dhr review and to investigate the manufacturing process, all potential hazards were reviewed to identify associated risk from infection. The expiration date is calculated as 24 months from the month of the dispersion start date. The dispersion started in (b)(6) 2015; therefore, the expiration of this lot is 02-2017. Based on the dhr review conducted, there were no abnormalities within the batch record and there is no indication that the production process may have contributed to this complaint. A query of the complaint database for the timeframe of 07mar2015? 07mar2016 was performed. There were no additional complaints received for this issue. There were approximately (b)(4) us wound dressing management devices sold in the past 12 months before this complaint. (b)(4). Conclusion: the additional description states that a biopsy was taken for histological evaluation; the biopsy showed an inflammatory reaction. The patient was then sent to an allergist. However, the last update provided by the customer does not indicate the results from the allergist. The integra meshed bilayer wound matrix package insert was reviewed for additional information. The contraindications section states that this device should not be used in patients with known sensitivity to bovine collagen or chondroitin materials. The warning and precautions section states that the following complications are possible with the use of the device: infection, chronic inflammation (initial application of wound dressing may be associated with transient, mild, localized inflammation), allergic reaction, excessive redness, pain or swelling. The insert also states that if any of the conditions occur, the device should be removed. The review of the dhr did not indicate that the manufacturing processes of lot 105na0325989 contributed to this complaint. Additionally, there have been no other complaints related to allergic reactions and this product line within the last year. The most probable root cause of this complaint is that the patient experienced a complication, as described within the package insert, and may have an allergy that he/she (and the doctor) was unaware of at the time the device was used. The complaint will be reopened and this section will be updated if results from the allergist are communicated by the customer to integra.
Patient Sequence No: 1, Text Type: N, H10
[47643571]
Additional information received via phone call with the surgeon 30mar2016: the procedure was done on the patient? S arm or hand. Bilayer mesh 4x10, lot 0105na0325989 was used. The biopsy of the product showed an inflammatory reaction. The patient was sent to an allergist. Results have not been returned from the allergist (yet). The patient? S symptoms improved after the removal of the product. He? S doing okay now.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1121308-2016-00007 |
| MDR Report Key | 5514653 |
| Date Received | 2016-03-21 |
| Date of Report | 2016-03-07 |
| Date of Event | 2016-03-05 |
| Date Mfgr Received | 2016-04-22 |
| Device Manufacturer Date | 2015-02-01 |
| Date Added to Maude | 2016-03-21 |
| 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 |
| Reporter Occupation | DENTAL HYGIENIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | USER MARIA LEONARD |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | INTEGRA LIFESCIENCES CORPORATION |
| Manufacturer Street | 105 MORGAN LANE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 08536 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BILAYER MATRIX WOUND DRESSING 8X10 SINGLE |
| Generic Name | BMWD |
| Product Code | MDD |
| Date Received | 2016-03-21 |
| Catalog Number | BMW8101 |
| Lot Number | 0105NA0325989 |
| Device Expiration Date | 2017-02-28 |
| 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 CORPORATION |
| Manufacturer Address | 105 MORGAN LANE 105 MORGAN LANE PLAINSBORO NJ 08536 US 08536 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-03-21 |